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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104442
• Other study ID #: CENA713BUS25
• Status: Completed
• Phase: Phase 4
• First received: February 28, 2005
• Last updated: December 17, 2007
• Start date: October 2003
• Est. completion date: April 2006

Study information

• Verified date: December 2007
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Rivastigmine

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in specific brain enzyme activity from baseline to week 13
Secondary	Correlate changes in specific brain enzyme activity at week 13 to cognition and behavior
Secondary	Changes in levels of protein biomarkers in Alzheimer's disease and neurodegeneration from baseline to week 13
Secondary	Correlate changes in specific brain enzyme activity after 13 weeks treatment to changes in global functioning at 13 and 26 weeks