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

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00104442

First received: February 28, 2005

Last updated: December 17, 2007

Last verified: December 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	February 28, 2005
Last Updated Date	December 17, 2007
Start Date ^ICMJE	October 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: May 30, 2006)	Changes in specific brain enzyme activity from baseline to week 13
Original Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Inhibition of targeted brain chemical
Change History	Complete list of historical versions of study NCT00104442 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 30, 2006)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of the Effects of Current Drug Treatments on Levels of Certain Brain Chemicals in Alzheimer's Disease
Official Title ^ICMJE	Study of the Effects of Current Drug Treatments on Levels of Certain Brain Chemicals in Alzheimer's Disease
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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Alzheimer's Disease
Intervention ^ICMJE	Drug: Rivastigmine
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	80
Completion Date	April 2006
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00104442
Other Study ID Numbers ^ICMJE	CENA713BUS25
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Novartis
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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