Study of the Effects of Current Drug Treatments on Levels of Certain Brain Chemicals in Alzheimer's Disease

Phase 4

Completed

• Conditions: Alzheimer's Disease

• Registration Number: NCT00104442
• Lead Sponsor: Novartis

Brief Summary

Alzheimer's disease is a medical illness that damages the brain and causes problems with memory, mood and behavior. A substance called acetylcholine (ACh), which is naturally produced in the body, plays an important role in the normal functioning of the brain. In subjects with Alzheimer's disease, the level of ACh is greatly reduced. Currently, there are three commonly prescribed drugs used for treating the symptoms of Alzheimer's disease by helping to maintain the level of ACh in the brain. This study will evaluate how much each of these drugs changes the levels of certain brain chemicals that are known to, or may play an important role in, Alzheimer's disease and its symptoms.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-02-28
• Study First Submitted QC: 2005-02-28
• Study First Posted: 2005-03-01
• Study Completion: 2006-04
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-17
• Last Update Posted: 2007-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Clinical diagnosis of mild to moderate Alzheimer's disease
• Must be able to swallow capsule/tablet
• Must have a caregiver who is available to attend all study visits

Exclusion Criteria

• Digestive problems related to peptic ulcer
• Experienced a heart attack or stroke in the last 6 months
• Serious/unstable asthma or severe pulmonary (lung) disease
• On current treatment with a blood thinner

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in specific brain enzyme activity from baseline to week 13

Secondary Outcome Measures

Name	Time	Method
Correlate changes in specific brain enzyme activity at week 13 to cognition and behavior
Changes in levels of protein biomarkers in Alzheimer's disease and neurodegeneration from baseline to week 13
Correlate changes in specific brain enzyme activity after 13 weeks treatment to changes in global functioning at 13 and 26 weeks

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States