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Evaluation of Galantamine in the Treatment of Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00000172
Recruitment Status : Completed
First Posted : November 1, 1999
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
National Institute on Aging (NIA)

Study Description
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Brief Summary:
Galantamine is an experimental drug being evaluated in the United States for the treatment of Alzheimer's disease. Results from previous clinical trials suggest that galantamine may improve cognitive performance in individuals with Alzheimer's disease. It is not a cure for Alzheimer's disease. Nerve cells in the brain responsible for memory and cognitive function communicate using a chemical called acetylcholine. Research has shown that deterioration of cells that produce acetylcholine in the brain affects thought processes. Galantamine is thought to work in two ways to increase the amount of acetylcholine available in the brain. It inhibits an enzyme that breaks down acetylcholine and it also stimulates the nicotinic receptors in the brain to release more acetylcholine.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Galantamine Phase 3

Detailed Description:
After a 1-month single-blind run in phase, 910 subjects will be titrated, over a period of up to 8 weeks, to target doses of either: 0 (placebo); 24 mg/day galantamine; 16 mg/day galantamine; or 8 mg/day galantamine, in a 2:2:2:1 randomization ratio. Double-blind treatment will continue for a total of 5 months. The change from baseline in ADAS-cog and CIVIC-plus scores at Month 5 will be the primary efficacy endpoints. Tolerability will be evaluated based on adverse event reports, laboratory values, ECG, and vital signs with particular focus on the adverse event rates in the slower titration schedule for 24 mg/day. Efficacy of 24 mg/day and 16 mg/day galantamine will be compared with that of placebo. Information on the dose response relationship of galantamine will be evaluated.
Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Placebo Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy Under a Slow-Titration Regimen

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   0 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Probable Alzheimer's disease
  • Mini-Mental State Examination (MMSE) 10-22 and ADAS greater than or equal to 18
  • Alzheimer's Disease Assessment Scale cognitive portion (ADAS-cog-11) score of at least 18
  • Opportunity for Activities of Daily Living
  • Caregiver
  • Subjects who live with or have regular daily visits from a responsible caregiver (visit frequency: preferably daily but at least 5 days/week). This includes a friend or relative or paid personnel. The caregiver should be capable of assisting with the subject's medication, prepared to attend with the subject for assessments, and willing to provide information about the subject.

Exclusion Criteria:

  • Conditions that could confound diagnosis
  • Neurodegenerative disorders
  • Acute cerebral trauma
  • Psychiatric disease
  • More than one infarct on CT/MRI scans
  • History of alcohol or drug abuse
  • Contradictions for a cholinominetic agent: seizures; ulcers; pulmonary conditions (including severe asthma); unstable angina; Afib; bradycardia less than 50; and AV block.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000172


Locations
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Sponsors and Collaborators
Janssen, LP
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00000172    
Other Study ID Numbers: IA0009
First Posted: November 1, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 2002
Keywords provided by National Institute on Aging (NIA):
Alzheimer's disease
Cholinergic agents
Cholinergic agonists
Cholinesterase inhibitors
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Galantamine
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents