Olfactory Deficits and Donepezil Treatment in Cognitively Impaired Elderly
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|ClinicalTrials.gov Identifier: NCT01951118|
Recruitment Status : Recruiting
First Posted : September 26, 2013
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Mild Cognitive Impairment Delirium, Dementia, Amnestic, Cognitive Disorders||Drug: Donepezil||Phase 4|
In this clinical trial, the investigators will evaluate, treat and follow two broad samples of adult patients at New York State Psychiatric Institute/Columbia University Medical Center. Study 1 will include 70 patients with amnestic Mild Cognitive Impairment (MCI). Study 2 will include 100 patients with probable Alzheimer's Disease (AD). Recruitment will be from clinics and/or advertisements. In the protocol, all 170 patients will receive baseline memory and olfactory assessments and are treated with donepezil. Patients will be followed for a total of 1 year. During this time, patients will be monitored closely by the study physician and will receive memory and olfactory assessments at weeks 0, 8, 26, and 52. In addition, an olfactory challenge test will be done at baseline.
This project will be of value in the selection of patients with MCI and AD for treatment based on the evaluation of olfaction tests to predict response to donepezil. Since mild cognitive impairment is widespread and Alzheimer's disease represents a major public health problem, this study has considerable public purpose and significance.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Olfactory Deficits and Donepezil Treatment in Cognitively Impaired Elderly|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
U.S. FDA Resources
Experimental: Donepezil Treatment & Atropine Challenge
Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item UPSIT immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks.
Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease. For patients who do not tolerate donepezil or have a history of intolerance to donepezil or cannot take donepezil for other reasons, treatment with other cholinesterase inhibitors (galantamine or rivastigmine) is permitted at any stage of the protocol. Data will be analyzed in two ways: for donepezil alone, and for any cholinesterase inhibitor (donepezil or rivastigmine or galantamine) as the intervention.
Other Name: Aricept
- Change over time in Selective Reminding Test (SRT) Scores [ Time Frame: Week 0, Week 8, Week 26, Week 52 ]The 12-item, 6-trial SRT is a memory measure used to assess verbal list learning and memory. The total number of words learned over six trials (total immediate recall), and delayed recall (after a 15-minute delay) will be obtained.
- Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) [ Time Frame: Week 0, Week 8, Week 26, Week 52 ]The modified ADAS-Cog is a cognitive battery that assesses learning, memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation.
- Clinician's Interview Based Impression (CIBIC-plus) [ Time Frame: Week 0, Week 2, Week 4, Week 8, Week 26, Week 52 ]The CIBIC-plus is a well-validated, reliable and widely used measure (range 1-7) of global improvement in AD and MCI trials.
- Pfeffer Functional Activities Questionnaire (FAQ) [ Time Frame: Week 0, Week 4, Week 8, Week 26, Week 52 ]FAQ is a widely used 10-item instrument that takes 3 minutes to administer and focuses on instrumental, social and cognitive functioning.
- Measurement of Everyday Cognition (Ecog) [ Time Frame: Week 0, Week 4, Week 8, Week 26, Week 52 ]This instrument has 40 items, takes 20 minutes to administer, and focuses on functional correlates of cognitive deficits.
- Mini-Mental State Examination - MMSE [ Time Frame: Week 0, Week 26, Week 52 ]
- Trail Making Test (Parts A and B) [ Time Frame: Week 0, Week 52 ]Parts A and B are composed of 25 circles. Patients are asked to scan the entire page and identify the next number or letter in a sequence.
- Wechsler Adult Intelligence Scale (WAIS) -III Digit Symbol Subtest [ Time Frame: Week 0, Week 52 ]
- Controlled Word Association (CFL) [ Time Frame: Week 0, Week 52 ]
- Boston Naming Test (BNT) [ Time Frame: Week 0, Week 52 ]
- Wechsler Memory Scale (WMS)-R Digit Span [ Time Frame: Week 0, Week 52. ]
- Treatment Emergent Symptom Scale (TESS) [ Time Frame: Week 0, Week 4, Week 8, Week 26, Week 52 ]TESS is widely used to evaluate somatic side effects. For each item, a rating is made on a 3-point scale, with an additional rating on the likelihood that the medication caused the side effect.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951118
|United States, New York|
|New York State Psychiatric Institute||Recruiting|
|New York, New York, United States, 10032|
|Contact: Richard E Chunga, B.A 646-774-7202 email@example.com|
|Contact: Michaela Ciovacco, B.A. 646-774-7204 firstname.lastname@example.org|
|Principal Investigator: Davangere Devanand, M.D.|
|Sub-Investigator: Gregory Pelton, M.D.|
|Sub-Investigator: Edward Huey, M.D.|
|Sub-Investigator: Karen Bell, M.D.|
|Principal Investigator:||Davangere Devanand, M.D.||Columbia University|