A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 3

Conditions

Alzheimer Disease

Dementia

Treatments

Drug: Galantamine hydrobromide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00236431

CR002014

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of galantamine treatment in patients with mild cognitive impairment.

Full description

This is an international, multicenter, double-blind, randomized, placebo-controlled trial. Patients with mild cognitive impairment (MCI) who are clinically at risk for development of Alzheimer's disease will be treated for 24 months with either placebo or galantamine hydrobromide. Memory and overall clinical improvement will be evaluated using the Alzheimer's Disease Assessment Scale with cognitive subscale adapted to MCI (ADAS-cog/MCI) and the Clinical Dementia Rating Sum of the Boxes (CDR-SB). Overall functional skills and the severity of dementia will be assessed with the Clinical Dementia Rating Sum of the Boxes (CDR-SB) and the overall Clinical Dementia Rating (CDR) score. Additional assessments include the Digit Symbol Substitution Test (DSST) to measure attention. Safety will be assessed using adverse event reports, vital signs, laboratory parameters, physical examination, and electrocardiogram. The study hypothesis is that treatment with galantamine will be well tolerated and, compared with placebo, will significantly improve the signs and symptoms associated with mild cognitive impairment in patients who are considered likely to develop Alzheimer's disease. Galantamine hydrobromide immediate-release tablets (4, 8, or 12 milligrams), taken by mouth 2 times daily: 8mg/day for 4 weeks, 16mg/day for 4 weeks, then increased to 24mg/day for the remainder of the 24-month trial. Doses may be reduced at investigator's discretion after 12 weeks.

Enrollment

1,063 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical decline of cognitive ability consistent with mild cognitive impairment
Delayed recall score <= 10 on a New York University paragraph recall test
Sufficient visual, hearing and communication capabilities and be willing to complete serial standard tests of cognitive function
Have a consistent informant to accompany them on scheduled visits
Be able to read, write and fully understand the language of the cognitive scales used in the study

Exclusion criteria

Neurodegenerative disorders such as Parkinson's disease
Cognitive impairment resulting from acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency states, infections such as meningitis or AIDS, or primary or metastatic cerebral neoplasia
Epilepsy
Significant psychiatric disease
Peptic ulcer disease
Clinically significant heart, lung, liver or kidney diseases
Pregnant or nursing women or those without adequate contraception