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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00104442

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: Rivastigmine	Phase IV

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia Memory

Drug Information available for: Rivastigmine SDZ-ENA 713

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Study of the Effects of Current Drug Treatments on Levels of Certain Brain Chemicals in Alzheimer's Disease

Further study details as provided by Novartis:

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

Estimated Enrollment:	80
Study Start Date:	October 2003
Study Completion Date:	April 2006

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104442

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis

More Information

Additional Information:

Click here for information about study sites in your area This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CENA713BUS25
Study First Received:	February 28, 2005
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00104442 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Alzheimer's disease
memory loss
dementia
senility

forgetful
geriatric
behavior
mood swings

Study placed in the following topic categories:

Neurotransmitter Agents
Rivastigmine
Alzheimer Disease
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Cholinergic Agents
Neuroprotective Agents

Cognition Disorders
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Amnesia
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Rivastigmine
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cholinergic Agents
Brain Diseases
Neurodegenerative Diseases

Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Therapeutic Uses
Dementia
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009