Evaluation of Galantamine in the Treatment of Alzheimer's Disease

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen, LP
• Treatments: Galantamine

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.