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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00104442

Enrollment

Registered

2005-03-01

Start date

2003-10-31

Completion date

2006-04-30

Last updated

2007-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

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

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.

Interventions

DRUGRivastigmine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Changes in specific brain enzyme activity from baseline to week 13	—

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026