Evaluation of Galantamine in the Treatment of Alzheimer's Disease

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 3

Conditions

Alzheimer Disease

Treatments

Drug: Galantamine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00000172

IA0009

Details and patient eligibility

About

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.

Full 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.

Sex

All

Volunteers

No Healthy Volunteers

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.