Electrophysiologic Measures of Treatment Response in Alzheimer Disease

NCT ID: NCT00018278

Last Updated: 2009-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-10-31
• Study Completion Date: 2001-09-30

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Aricept

Intervention Type: DRUG

Exelon

Intervention Type: DRUG

Nicoderm Patch

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Principal Investigators

Vincente Iragui, M.D., Ph.D

Role:

Shuanna Morris, Ph.D.

Role:

Locations

Department of Veterans Affairs

San Diego, California, United States

Countries

United States

Other Identifiers

AGCG-004-98S

Identifier Type: -

Identifier Source: org_study_id