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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Effects of Current Drug Treatments on Levels of Certain Brain Chemicals in Alzheimer's Disease

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

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

Keywords provided by Novartis:
Alzheimer's disease
memory loss
dementia
senility
forgetful
geriatric
behavior
mood swings

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014