Symptoms and General Pathology

All Conditions

Nervous System Diseases

Rare Diseases

Chronic Pain

Peripheral Nervous System Diseases

Pain

Neuromuscular Diseases

Chronic Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Nootropic Agents

Oxaliplatin

Donepezil

Cholinesterase Inhibitors

Enzyme Inhibitors

Cholinergic Agents

Neurotransmitter Agents

5 mg/day for 4 weeks then 10 mg/day for 12 weeks

5 mg daily for 4 weeks + 10 mg daily for 12 weeks according to tolerance or efficacy

DONEPEZIL

PLACEBO

Denis PEZET

The use of oxaliplatin in the treatment of colorectal or pancreas cancer induces (\>75% of patients) severe sensorimotor neuropathy decreasing the quality of life of cancer survivors. Today, no treatment remains univocal for these peripheral neuropathies. But preclinical works have demonstrated that donepezil (acetylcholinesterase inhibitor use for Alzheimer's disease) was able to prevent and treat neuropathic symptoms in oxaliplatin-treated rats.

Present study aims to assess the therapeutic efficacy of donepezil on oxaliplatin-induced peripheral neuropathy (OIPN) in cancer survivors. Bibliographic data suggests an antineuropathic effect of donepezil in human and animal models. In clinic, a study have shown in healthy volunteers that donepezil (associated with gabapentin) reduced the pain threshold (better than gabapentin alone) caused by stimulation of the sural nerve, without severe adverse effect. Similarly, two studies in patients with neuropathic pain demonstrated that donepezil increases analgesic effect of gabapentin. Finally, a case report demonstrated an analgesic effect of donepezil in painful Alzheimer's disease patients. In animals, several studies demonstrated that donepezil induces analgesic and neuroprotective effects. Recently, a preclinical study demonstrated that donepezil induced antineuropathic effect in diabetic mice with neuropathic pain. Research unit INSERM U1107 (partner of the DONEPEZOX study) demonstrated the antineuropathic effects of donepezil in several animal models of chemotherapy-induced peripheral neuropathies, and very recently, a study have confirmed these results with oxaliplatin and cisplatin. These clinical and preclinical data have thus highlighted the potential beneficial effect of donepezil on neuropathic symptoms, without any significant adverse effects. Therefore the hypothesis is that the use of donepezil could reduce the symptoms of OIPN, limit the decrease in quality of life and the appearance of comorbidities (anxiety/depression) in cancer survivors.

For this purpose, the investigators propose here a proof of concept, multicentre, phase II, randomised, double-blind, placebo-controlled clinical study. The primary objective will be the curative efficacy of donepezil on the severity of OIPN in patients who have completed oxaliplatin-based chemotherapy for the treatment of colorectal or pancreas cancer and have peripheral neuropathy of grade ≥2. This will be assessed using the EORTC QLQ-CIPN20 sensory scale. Our methodological choice to use the QLQ-CIPN20 as the primary endpoint will allow us to more accurately (and in a standardized manner) characterize neuropathic symptoms and assess the therapeutic effect of donepezil on these symptoms. In addition, as secondary objectives, we will study the effect of donepezil on neuropathic pain, the intensity of neuropathic symptoms, health-related quality of life, and the tolerance of donepezil.

The 80 patients required will be randomized (1:1) to receive either placebo or donepezil (5 mg daily for 4 weeks and then 10 mg daily for 12 weeks as a single dose and according to tolerance and efficacy). Patients will be followed for 1 month after the end of treatment to assess the OIPN. As a proof of concept study, responder rate will be assessed only for Donepezil arm (primary objective) and compared between each treatment arm (secondary objective) after a minimum of 12 weeks of treatment. A responder will be defined as a patient with a decrease of neuropathic grade according to CIPN20 sensory score compraed to baseline.

Donepezil for Oxaliplatin-induced Neuropathy Peripheral Neuropathy: Proof of Concept Study

Evaluation of the Efficacy of Donepezil in the Treatment of Oxaliplatin-induced Peripheral Neuropathy: Proof of Concept Study

A self-reported questionnaire, consisting of 20 questions which assess the symptoms and functional limitations of CIPN from the patients' perspective. The questionnaire is divided in 3 subscales: sensory, motor, and autonomic and gives a comprehensive picture of the nature, frequency, and severity of CIPN.

For each subscale and for the entire questionnaire, a score from 0 to 100 is generated. The higher the score, the more severe the neuropathic symptoms.

The NRS is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. The score of 0 = No pain and 10 = worst possible pain.

The interview portion of the DN4 questionnaire is a clinician-administered screening tool for neuropathic pain.

The questionnaire includes 7 items, grouped into two questions. Each item, is answered as either YES or NO.

A final cumulative patient's score is obtained by allocating 1 point for each YES and 0 point for each NO. If the patient's score ≥3/7, the test is positive.

This evaluation will be carried out only if the 11-point pain NRS ≥4/10.

This self-reported questionnaire assesses different neuropathic pain symptoms. The French NPSI includes 12 items that discriminates and quantifies five distinct dimensions of neuropathic pain.

This evaluation will be carried out only if the 11-point pain NRS ≥4/10.

This EORTC self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.

This self-reported questionnaire permits to detect anxiety and depressive disorders. There are 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and 7 to the depressive dimension (total D), thus obtaining two scores (maximum score of each score = 21). To detect anxiety and depressive symptoms, the following interpretation is proposed for each of the scores (A and D):

* ≤7: absence of symptomatology
* 8 to 10: suspicious symptomatology
* ≥11: certain symptomatology

PGIC is aimed at assessing the general effectiveness of the treatment. This scale consists of 7 level descriptors answering the question "How are you?" distributed in three ways: (i) improved (very/medium/slightly), (ii) unchanged and (iii) aggravated (slight/medium/very).

Federation Francophone de Cancerologie Digestive

University Hospital, Clermont-Ferrand

During the 12-week Double-Blind Phase, subjects will receive oral donepezil hydrochloride tablets starting at a dose of 3 mg once daily. Doses will be increased incrementally at successive 3-week intervals on the basis of weight and tolerability. The final daily dose will be 3, 5, or 10 mg depending on body weight.

During the Blinded Extension Phase, all subjects will receive active treatment (donepezil).

Donepezil hydrochloride

During the 12-week Double-Blind Phase, subjects will receive matching placebo tablets (3, 5, of 10 mg) once daily.

During the 12-week Blinded Extension Phase, all subjects will receive active treatment (donepezil).

Placebo

The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil in children with persistent attention impairment that is present at least 12 months after the completion of cancer treatment.

This is a double-blind, placebo-controlled, parallel group study in pediatric subjects who have persistent attention impairment following treatment for cancer. This trial has three phases: (1) pre-randomization to establish eligibility, (2) a 12-week, double-blind, placebo-controlled, parallel-group phase with dose escalation based on body weight, (3) a 12-week, blinded extension phase during which all subjects will receive active drug.

Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment

Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment

TOVA-CPT test has a standardized computer game-like format that tests attention and simple impulse control. It precisely measures a person's reaction time to clicking on correct targets versus incorrect targets. Scores are based on the number of "Hits" (correct responses), omission errors (failure to respond), commission errors/"False Alarms" (incorrect responses), response time, and sensitivity ("d-prime"). "D-prime" a dimensionless statistics is a measure of distractibility and reflects how well a person reacts correctly versus incorrectly. A higher value of "d-prime" is reached by having more "Hits" (correct response) and fewer "False Alarms" (incorrect response). Analysis was based on three factors: the "d-prime" standard score, reaction time variability standard score, and response time standard score. Standard scores less than or equal to 80 were significant for an attention deficit disorder. Standard scores greater than 80 were not significant for an attention deficit disorder.

The Reaction Time Variability is defined as the time measurement of how consistently the switch is pressed. The Response Time is the measurement of how fast or slow information is processed and responded to by the participant. The testing process was as described in a previous outcome measure. Standard scores less than or equal to 80 were significant for an attention deficit disorder. Standard scores greater than 80 were not significant for an attention deficit disorder.

Behavioral Rating Inventory of Executive Functioning test evaluates impairment of executive function(planning and organization),memory,and sustained attention in children aged 5-18 years with wide range of developmental and acquired neurological conditions.Survey assess parent/guardian's perception of their child's executive functioning in home and school environments,which relate to daily function(as judged by parent).Each survey contains 86 items scored as;1(behavior is never a problem),2(behavior is sometimes a problem),or 3(behavior is often a problem).Data was presented as t-scores(raw scale scores are used to generate t-scores)for Global Executive Composite Score(t-score range 72-216),Behavioral Regulation Index(t-score range 28-84;inhibit,shift,and emotional control),Metacognition Inde (t-score range 44-132;initiate,working memory,plan/organize,organization of materials, and monitor),and Working Memory Subscale(t-score range 35-90).Higher scores indicate decline in performance.

Eisai Limited

Eisai Inc.

Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.

Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily

Donepezil Double-Blind Phase

Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily

Placebo Double-Blind Phase

Donepezil Blinded Extension Phase

Placebo Blinded Extension Phase

Total

Age, Continuous

Sex: Female, Male

Safety population (SP) included randomized participants who took at least one dose of study medication and who had at least one post-Baseline safety assessment. One participant from the placebo group was not evaluable for safety resulting in one less total participants (71) in the SP as compared to the randomized population (72).

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data.

Eisai Medical Information

P-values, least squares (LS) mean, and 95% confidence interval (CI) were obtained from Analysis of Covariance (ANCOVA) model with treatment group as a factor and Baseline value as covariate.

Intent-to-Treat (ITT) Last Observed Carried Forward (LOCF) population included all safety participants for whom the TOVA-CPT "d-prime" standard score was available at both Screening and at least one "d-prime" score from the treatment period, in addition to having a post-Baseline safety assessment.

Change From Baseline in the Test of Variables in Attention-Continuous Performance Test (TOVA-CPT) "D-prime" Standard Score (SS) at Week 12

P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.

Intent-to-Treat (ITT) Last Observed Carried Forward (LOCF) population included all safety participants for whom the TOVA-CPT d-prime standard score was available at both Screening and at least one visit after the first dose of study drug during the Double-Blind Phase.

Change From Baseline in the TOVA-CPT "D-prime" Standard Score (SS) at Week 6

RTVSS Change from Baseline to Week 6 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.

RTVSS Change from Baseline to Week 12 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.

RTSS Change from Baseline to Week 6 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.

RTSS Change from Baseline to Week 12 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.

RTVSS (Week 6)

RTVSS (Week 12)

RTSS (Week 6)

RTSS (Week 12)

Change From Baseline in the Reaction Time Variability Standard Score (RTVSS) and Response Time Standard Score (RTSS) at Weeks 6 and 12

Global Executive Composite Score Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.

Behavioral Regulation Index Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.

Metacognition Index Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.

Working Memory Scale Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.

Global Executive Composite Score

Behavioral Regulation Index

Metacognition Index

Working Memory Scale

Change From Baseline in the Global Executive Composite Score, Behavioral Regulation Index, Metacognition Index, and Working Memory Subscale

Double-Blind Phase

Blinded Extension Phase

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Urinary Retention

Urination Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Patients were randomly divided into experimental group and control group. The experimental group received routine postoperative treatment and took donepezil 5mg orally before going to bed every night from the first day after surgery.

Usual care

Qing Chen, MD

Qing Chen, Master

Meimei Guan, Master

Patients were randomly divided into experimental group and control group. The control group received routine postoperative treatment, while the experimental group took donepezil 5mg orally before going to bed every night from the first day after surgery. The catheter was removed and residual urine was measured in both groups 14 days after surgery, the catheter was successfully removed when the residual urine was less than 100ml. After 14 days, the patient was returned to the hospital for residual urine test, and the residual urine was repeated until the residual urine volume was less than or equal to 100ml. The incidence of postoperative urinary retention and adverse drug reactions were compared between the two groups.

This study hypothesized that donepezil could effectively reduce the incidence of urinary retention in cervical cancer patients after extensive total hysterectomy. A total of 108 patients with cervical cancer who underwent abdominal radical hysterectomy in our department from June 1, 2022 to May 31, 2023 were randomly divided into two groups, the experimental group (n = 54) and the control group (n = 54). The incidence of postoperative urinary retention and adverse drug reactions were compared between the two groups.

A. Screening accords with the standard set of subjects, abdominal widely whole palace resection, BiXing random grouping, experimental group from the first day after oral donnelly, pp every night before going to bed together 5 mg, two groups of patients with the rest of the regular place Agreement (including antibiotics to 48 h, postoperative indwelling catheterization, perineum wipe to wash the bid, wound dressing, etc.);

B. The catheter was removed and the residual urine was measured 14 days after operation. The residual urine was ≤100ml, and the catheter was successfully removed. The patients in the experimental group stopped taking the drug, and the residual urine was \> 100ml.

C. Residual urine of patients with urinary retention was measured again 14 days later, and the residual urine was ≤100ml. Patients in the experimental group stopped the drug, and the residual urine was \> 100ml. Intermittent catheterization was continued, and patients in the experimental group continued to take the drug until the residual urine volume was ≤100ml.

D. This cycle was carried out until the residual urine volume of the last enrolled patient was less than 100ml. The incidence of postoperative urinary retention and adverse drug reactions were compared between the two groups.

Donepezil Prevents Urinary Retention After Extensive Total Hysterectomy

Effect of Donepezil on Prevention of Postoperative Urinary Retention in Patients Undergoing Extensive Total Hysterectomy

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Cognitive Dysfunction

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Participants will be asked to take one 5 mg tablet of donepezil daily for 6 weeks followed by two 5 mg tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.

Participants will be asked to take one tablet of matching placebo daily for 6 weeks followed by two tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.

Participants will be asked to take one 5 mg tablet of donepezil daily for 6 weeks followed by two 5mg tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.

Donepezil 5 mg

Stephen R Rapp, PhD

This study is to compare the safety and effects of donepezil (Aricept) for patients reporting cognitive or memory issues after receiving chemotherapy for breast cancer. Patients will receive either donepezil or placebo for 24 weeks. The primary objective is to see if memory improves with the use of donepezil during the study.

Randomized, double-blind, placebo-controlled study with 24 weeks of exposure to drug or placebo followed by a 12 week wash-out period. Patients who meet the eligibility criteria will be stratified by age (\<50, 50-59, 60-69, ≥70) and randomized to donepezil or placebo with equal probability. A total of 276 patients will be enrolled (138 per arm). We expect an accrual rate of 7-10 participants per month based on our prior feasibility study. We expect the study to be complete within 40 months.

Participants will be asked to take one 5mg tablet of donepezil or one tablet of matching placebo orally once a day for 6 weeks followed by two 5mg tablets (10mg total) of donepezil or two placebo tablets orally once a day for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.

Time points for performing study assessments. Participants will be administered the cognitive battery of tests and questionnaires at baseline, week 12, week 24 and week 36. In addition, a single vial of blood will be drawn at baseline for apolipoprotein E (APOE) genotyping and subsequent bioassays (pending supplemental funding).

Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil

A Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil in Chemotherapy Exposed Breast Cancer Survivors With Cognitive Impairment

Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base is committed to following the NIH Statement on Sharing Research Data. As of July 2018, the Wake Forest (WF) NCORP Research Base (RB) signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI National Clinical Trials Network (NCTN)/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide.

Hopkins Verbal Learning Test-Revised (HVLT-R): The HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to patients on three successive learning trials. Free recall scores are recorded for each learning trial. After a 20-minute interval during which patients complete other non-interfering tasks and questionnaires they are asked to recall the target words. Range is 0-36 with higher values representing better verbal learning and memory.

The digit symbol coding (DSC) test measures processing speed, working memory, visuospatial processing, and attention. The DSC test measures processing speed. It requires respondents to transcribe symbols (e.g., \>) associated with a number (0-9) into empty boxes beneath a series of randomly ordered numbers. Total score is number of correctly transcribed symbols in 2 minutes. Scores range from 0 to 100, with higher scores indicating higher cognitive function.

This self-report scale assesses fatigue. Scale ranges from 7 to 35 converted to T-scale ranging 29.4 to 83.2 Higher scores representing more fatigue.

The FACT-Cog is a patient-reported outcome (PRO) that includes subscales to measure Perceived Cognitive Impairment (PCI, n = 20 items, score range 0-80). Higher FACT-Cog PCI scores are better and indicate less cognitive impairment.

The Controlled Oral Word Association Test from the Halstead-Reitan Neuropsychological Battery is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). Scores are the sum of all acceptable words. Minimum is 0 with no specified maximum; higher values represent better verbal fluency.

TMT Part A consists of 25 circles on a piece of paper with the numbers 1 to 25 written randomly in each. For Part A, the person is tasked with drawing a line from one circle to the next in ascending numerical order, from 1 to 25, as quickly as possible. The lines between the circles are referred to as the "trail." Range 1-300 in seconds. Lower values indicate completing task faster with less difficulty. It is a measure of executive functioning with lower values being better.

TMT Part B also consists of 25 circles on a piece of paper, But, rather than all of the circles containing numbers, they contain numbers (1 to 12) and letters (A through L). For Part B, the person is tasked with connecting the circles in ascending order, alternating back and forth from numbers to letters. In other words, the "trail" would be connected like this:1-A-2-B-3-C-4-D-5-E-6-F-7-G-8-H-9-I-10-J-11-K-12-L-13. The range 1-300 seconds. Higher values indicate worse executive functioning.

The Digit Span Task (Backwards-Only Version) measures working memory. On each question the participant repeats the numbers in reverse order of that presented aloud by the examiner (e.g., If the examiner says "5-6", the correct response would be "6-5"; If the examiner says "5-1-7-4-2-3-8", the correct response would be "8-3-2-4-7-1-5"). Score is 0 to 16 with higher scores representing better working memory.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Each adverse event will include the date of onset, date of resolution, severity, and the relationship to the study agent or intervention, and any action taken with respect to the study agent or intervention. Grade 1 and 2 adverse events (AEs), expected grade 3 or grade 4 AEs will not be collected. Unexpected grade 3 AEs that are unrelated or unlikely will also not be collected.

Participants will be asked to take one 5 mg tablet of donepezil daily for 6 weeks followed by two 5 mg tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.

Donepezil 5 mg: Participants will be asked to take one 5 mg tablet of donepezil daily for 6 weeks followed by two 5mg tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.

Participants will be asked to take one tablet of matching placebo daily for 6 weeks followed by two tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.

Placebo: Participants will be asked to take one tablet of matching placebo daily for 6 weeks followed by two tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.

Age, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Body Mass Index (BMI)

Chemotherapy Received

Menopausal Status

Participant reported use of hormonal therapies (for their breast cancer treatment) at time of study enrollment.

Currently taking hormonal therapy

Time since completed chemotherapy (months)

The Shipley Institute of Living Scale-Version 2 Vocabulary subtest was used to estimate premorbid cognitive function (score range, 0-40). Higher values represent better cognitive function.

Shipley Institute of Living Scale-2 Vocabulary

Highest level of Education Completed

Hopkins Verbal Learning Test- Revised (HVLT-R): Total

Measure Description: Hopkins Verbal Learning Test-Revised (HVLT-R): The HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to patients on three successive learning trials. Free recall scores are recorded for each learning trial. After a 20-minute interval during which patients complete other non-interfering tasks and questionnaires they are asked to recall the target words. Delayed Recall range is 0-12 with higher values representing better verbal learning and memory.

Hopkins Verbal Learning Test- Revised (HVLT-R): Delayed Recall

Measure Description: Hopkins Verbal Learning Test-Revised (HVLT-R): The HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to patients on three successive learning trials. Free recall scores are recorded for each learning trial. After a 20-minute interval during which patients complete other non-interfering tasks and questionnaires they are asked to recall the target words. Recognition memory range is 0-12 with higher values representing better verbal learning and memory.

Hopkins Verbal Learning Test- Revised (HVLT-R): Recognition

Measure Description: Hopkins Verbal Learning Test-Revised (HVLT-R): The HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to patients on three successive learning trials. Free recall scores are recorded for each learning trial. After a 20-minute interval during which patients complete other non-interfering tasks and questionnaires they are asked to recall the target words. Discrimination range is -12 to 12 with higher values representing better verbal learning and memory.

Hopkins Verbal Learning Test- Revised (HVLT-R): Discrimination

TMT Part A consists of 25 circles on a piece of paper with the numbers 1 to 25 written randomly in each. For Part A, the person is tasked with drawing a line from one circle to the next in ascending numerical order, from 1 to 25, as quickly as possible. The lines between the circles are referred to as the "trail." Range 1-300 in seconds. Lower values indicate completing task faster with less difficulty. It is a measure of executive functioning with lower values being better.

Trail Making Test (TMT) - A

TMT Part B also consists of 25 circles on a piece of paper, But, rather than all of the circles containing numbers, they contain numbers (1 to 12) and letters (A through L). For Part B, the person is tasked with connecting the circles in ascending order, alternating back and forth from numbers to letters. In other words, the "trail" would be connected like this:1-A-2-B-3-C-4-D-5-E-6-F-7-G-8-H-9-I-10-J-11-K-12-L-13. The range 1-300 seconds. Higher values indicate worse executive functioning.

Trail Making Test (TMT) - B

Controlled Oral Word Association (COWA)

The Digit Span Task (Backwards-Only Child Version) measures working memory. On each question the participant repeats the numbers in reverse order of that presented aloud by the examiner (e.g., If the examiner says "5-6", the correct response would be "6-5"; If the examiner says "5-1-7-4-2-3-8", the correct response would be "8-3-2-4-7-1-5"). Score is 0 to 16 with higher scores representing better working memory.

Digit Span Test Backward

The digit symbol test measures processing speed, working memory, visuospatial processing, and attention. Scores range from 0 to 100, with higher scores indicating higher cognitive function.

Digit Symbol Coding

The Functional Assessment of Cancer Therapy (FACT)-Cognition is a patient-reported outcome (PRO) that includes subscales to measure Perceived Cognitive Impairment (PCI, n = 20 items, score range 0-80). Higher FACT-Cog PCI scores are better and indicate less cognitive impairment.

The Functional Assessment of Cancer Therapy (FACT)-Cognition: Perceived Cognitive Impairment

This self-report scale assesses fatigue. Scores range from 7 to 35 and are converted to a T-scale with ranges from 29.4 to 83.2. Higher scores representing more fatigue.

Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 7a

All participants that were enrolled and randomized completed baseline assessments.

Our mainly non-Hispanic, white sample of breast cancer survivors, while geographically diverse, is not representative of all survivors. A lack of validated alternate forms of most of our tests may have contributed to a practice effect. We did not collect estrogen receptor, progesterone receptor or human epidermal growth factor receptor 2 (HER2) status.

Lead Biostatistician (Emily Dressler, PhD)

With a sample size of 266, there was 90% power to detect a treatment difference of 2 words for HVLT-R total recall score (SD=4.26, effect size=0.47) with a two-sided 5% level of significance. This calculation assumed an ANCOVA model analysis with 25% dropout and 2% missing data at end of treatment. A single interim analysis for futility occurred after 138 participants, with stopping rule of two-sided p-value \< 0.0154. This design required 3.5% more than fixed design, increasing total to 276.

12 Weeks

24 Weeks

36 Weeks

Intent to treat analysis. Considered and utilized all data available at each timepoint.

Hopkins Verbal Learning Test-Revised (HVLT-R) - Total

Intent to treat analysis. All available data from all participants utilized in models.

Digit Symbol Coding Results

Intent to treat: all participants and timepoints available were utilized.

PROMIS 7-item Fatigue Scale Converted to T-scale Results

Intent to treat analyses: all available timepoints and participant data utilized.

FACT-Cognition (Version 3): Perceived Cognitive Impairment

Intent to treat analysis. All available timepoints from all participants utilized.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Donepezil for Oxaliplatin-induced Neuropathy Peripheral Neuropathy: Proof of Concept Study	NCT05254639	Digestive Oncol... Supportive Care	DONEPEZIL PLACEBO	18 Years -	University Hospital, Clermont-Ferrand
Donepezil for Oxaliplatin-induced Neuropathy Peripheral Neuropathy: Proof of Concept Study	NCT05254639	Digestive Oncol... Supportive Care	DONEPEZIL PLACEBO	18 Years -	University Hospital, Clermont-Ferrand
Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment	NCT00688376	Attention Impai...	Donepezil hydro... Placebo	6 Years - 17 Years	Eisai Inc.
Donepezil Prevents Urinary Retention After Extensive Total Hysterectomy	NCT05540977	Urinary Retenti...	Donepezil Usual care	18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil	NCT02822573	Cognitive Dysfu... Memory Impairme...	Donepezil 5 mg Placebo	18 Years - 75 Years	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for donepezil

Every month we try and update this database with for donepezil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for donepezil

Every month we try and update this database with for donepezil cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for donepezil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.