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

NCT00236574

CR003145

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. Following a 4 week screening period, patients with mild cognitive impairment (MCI), who are clinically at risk for development of Alzheimer's disease, will be randomized to treatment with either placebo or galantamine for 24 months with either placebo or a flexible dose of galantamine. Efficacy will be evaluated by measures of memory and cognition (Alzheimer's Disease Assessment Scale of cognition for MCI [ADAS-cog/MCI] and the Clinical Dementia Rating Sum of the Boxes [CDR-SB]), global severity of dementia (Clinical Dementia Rating [CDR]), functionality (Alzheimer's Disease Cooperative Study - Activities of Daily Living adapted to MCI [ADCS-ADL/MCI]), and changes on serial magnetic resonance imaging (MRI). Safety will be assessed using adverse event reports, vital signs, laboratory parameters, physical examination and electrocardiograms. The primary study hypothesis is that galantamine will improve memory deficits associated with mild cognitive impairment and therefore improve or stabilize the patient's cognitive abilities. A second study hypothesis is that treatment with galantamine slows or delays conversion of mild cognitive impairment to the dementia often associated with probable Alzheimer's disease in these patients. The third study hypothesis is that the treatment will be well tolerated by the patients. Galantamine hydrobromide immediate-release tablets (4, 8, and 12 milligrams (mg)) taken by mouth 2 times daily: 4 weeks at 8mg/day, 4 weeks at 16mg/day, increased to 24mg/day for the remainder of the 24-month trial. Dose may be reduced at investigator's discretion after 12 weeks.

Enrollment

974 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 less than or equal to 10 on New York University paragraph recall test
Sufficient visual, hearing and communication capabilities and willingness 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

Contraindications for magnetic resonance imaging, for example, presence of pacemaker or presence of metal in high risk areas
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 of metastatic cerebral neoplasia
Significant endocrine or metabolic disease
Mental retardation
Women who are pregnant, nursing, or lacking adequate contraception