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OpenTrials
Completed

NCT Number: NCT00104442

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Dementia Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivastigmine

Drug

Primary outcomes

  1. Changes in specific brain enzyme activity from baseline to week 13

Secondary outcomes

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

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

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2003
Study completion
2006
First posted
Mar 1, 2005
Registry last updated
Dec 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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