Study of the Effects of Current Drug Treatments on Levels of Certain Brain Chemicals in Alzheimer's Disease
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Changes in specific brain enzyme activity from baseline to week 13
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Changes in specific brain enzyme activity from baseline to week 13
Secondary Outcomes
- 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