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

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Rivastigmine

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, memory loss, dementia, senility, forgetful, geriatric, behavior, mood swings

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Novartis Pharmaceuticals

Outcomes

Primary Outcome Measures

Changes in specific brain enzyme activity from baseline to week 13

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00104442

First Posted

February 28, 2005

Last Updated

December 17, 2007

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00104442

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Rivastigmine

Primary Outcome Measure Information:

Title

Changes in specific brain enzyme activity from baseline to week 13

Secondary Outcome Measure Information:

Title

Correlate changes in specific brain enzyme activity at week 13 to cognition and behavior

Title

Changes in levels of protein biomarkers in Alzheimer's disease and neurodegeneration from baseline to week 13

Title

Correlate changes in specific brain enzyme activity after 13 weeks treatment to changes in global functioning at 13 and 26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Novartis Pharmaceuticals

City

East Hanover

State/Province

New Jersey

ZIP/Postal Code

07936

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.novartisclinicaltrials.com/etrials/searchTrial.do?trialID=306

Description

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

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