Back to resultsElectrophysiologic Measures of Treatment Response in Alzheimer Disease
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aricept
Exelon
Nicoderm Patch
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
Patients diagnosed with mild to moderate probable Alzheimer's disease (mini-mental state exam scores between 15-27), and normal controls (age generally between 60-85). Subjects must either be planning to start daily cholinesterase therapy (e.g. Aricept, Exelon) or willing to try a transdermal nicotine patch for two 8 hour periods.
Sites / Locations
- Department of Veterans Affairs
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00018278
First Posted
July 3, 2001
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00018278
Brief Title
Electrophysiologic Measures of Treatment Response in Alzheimer Disease
Official Title
Verbal Memory ERPs as Indices of Treatment Response in Alzheimer Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
The main purpose of this study is to determine the electrophysiological effects of cholinergic therapy (cholinesterase inhibitors and transdermal nicotine) in Alzheimer disease. The attempt will be to locate electrophysiological markers and predictors of cognitive and clinical treatment response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aricept
Intervention Type
Drug
Intervention Name(s)
Exelon
Intervention Type
Drug
Intervention Name(s)
Nicoderm Patch
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Patients diagnosed with mild to moderate probable Alzheimer's disease (mini-mental state exam scores between 15-27), and normal controls (age generally between 60-85). Subjects must either be planning to start daily cholinesterase therapy (e.g. Aricept, Exelon) or willing to try a transdermal nicotine patch for two 8 hour periods.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincente Iragui, M.D., Ph.D
First Name & Middle Initial & Last Name & Degree
Shuanna Morris, Ph.D.
Facility Information:
Facility Name
Department of Veterans Affairs
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Electrophysiologic Measures of Treatment Response in Alzheimer Disease
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