Advertisement

Topics

Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil - WF 97116

2016-07-05 22:38:21 | BioPortfolio

Summary

This study is to compare the safety and effects of donepezil (Aricept) or if it decreases memory loss after receiving chemotherapy for breast cancer.

Description

A randomized, placebo controlled, double-blind, parallel group Phase 3 design will be used to assess the effect of 24 weeks of donepezil on cognitive function (memory) in breast cancer survivors who report having cognitive dysfunction and demonstrate memory impairment 1-5 year post chemotherapy. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Cognitive Dysfunction

Intervention

Donepezil 5 mg, Placebo

Location

Wake Forest School of Medicine
Winston Salem
North Carolina
United States
27157

Status

Not yet recruiting

Source

Wake Forest NCORP Research Base

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-07-05T22:38:21-0400

Clinical Trials [1948 Associated Clinical Trials listed on BioPortfolio]

Donepezil Attenuate Postoperative Cognitive Dysfunction

Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective t...

Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome

The purpose of this study is to determine whether donepezil HCl is effective and safe in improving cognitive dysfunction exhibited by children and adolescents with Down syndrome. Effective...

Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17

The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of the cognitive dysfunction shown by children with Down syndrome, a...

Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10

The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of cognitive dysfunction shown by children with Down syndrome, aged ...

The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil

The purpose of this study is to determine if there is improvement or measurable change in cognition after only one month of treatment with donepezil when using a computerized test battery....

PubMed Articles [7519 Associated PubMed Articles listed on BioPortfolio]

The effects of donepezil on phencyclidine-induced cognitive deficits in a mouse model of schizophrenia.

Donepezil is the first-line of treatment for Alzheimer's disease (AD), which improves cognitive impairment effectively, but whether it has an impact on cognitive impairment in schizophrenia remains un...

The efficacy and safety of memantine for the treatment of Alzheimer's disease.

Currently, five pharmacotherapeutic options are available to treat Alzheimer's disease: memantine; the three cholinesterase inhibitors donepezil, galantamine, and rivastigmine; and combination treatme...

Guanfacine treatment for prefrontal cognitive dysfunction in older participants: a randomized clinical trial.

This study evaluated the effect of the alpha-2A-adrenoceptor agonist guanfacine on prefrontally mediated cognitive functions, as well as quality of life and global function in healthy older participan...

The 5-HT receptor antagonist ondansetron potentiates the effects of the acetylcholinesterase inhibitor donepezil on neuronal network oscillations in the rat dorsal hippocampus.

Cognitive impairments in Alzheimer's disease (AD) have been associated with alterations in neuronal oscillatory activity, of which hippocampal theta and gamma oscillations are essential for the coordi...

Female Sexual Dysfunction and the Placebo Effect: A Meta-analysis.

To quantify the placebo effect of various pharmacologic modalities including neuromodulators, hormonal agents, and onabotulinum toxin A for female sexual dysfunction.

Medical and Biotech [MESH] Definitions

Diminished or impaired mental and/or intellectual function.

A progressive form of dementia characterized by the global loss of language abilities and initial preservation of other cognitive functions. Fluent and nonfluent subtypes have been described. Eventually a pattern of global cognitive dysfunction, similar to ALZHEIMER DISEASE, emerges. Pathologically, there are no Alzheimer or PICK DISEASE like changes, however, spongiform changes of cortical layers II and III are present in the TEMPORAL LOBE and FRONTAL LOBE. (From Brain 1998 Jan;121(Pt 1):115-26)

A neuropsychological test designed to assess different memory functions. It may incorporate an optional cognitive exam (Brief Cognitive Status Exam) that helps to assess memory related cognitive function.

Disorders of verbal and nonverbal communication caused by receptive or expressive LANGUAGE DISORDERS, cognitive dysfunction (e.g., MENTAL RETARDATION), psychiatric conditions, and HEARING DISORDERS.

Cognitive disorders including delirium, dementia, and other cognitive disorders. These may be the result of substance use, trauma, or other causes.

More From BioPortfolio on "Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil - WF 97116"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Breast Cancer
Track and monitor developments in breast cancer research and commercial development.  Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...


Searches Linking to this Trial