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

NCT00104442 | Completed Phase 4

• 1 other identifier: CENA713BUS25
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; memory loss; dementia; senility; forgetful; geriatric; behavior; mood swings

Outcome Measures

Primary Outcomes (1)

• Changes in specific brain enzyme activity from baseline to week 13

Secondary Outcomes (3)

• 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

Interventions

Rivastigmine DRUG

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Related Links

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MeSH Terms

Conditions

Alzheimer Disease; Memory Disorders; Dementia; Behavior

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 28, 2005
• First Posted: March 1, 2005
• Study Start: October 1, 2003
• Study Completion: April 1, 2006
• Last Updated: December 21, 2007

Record last verified: 2007-12

Locations

US (1)