Placebo-Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy of a Controlled-Release Formulation
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer Disease; Dementia
Intervention: galantamine hydrobromide (Drug)
Phase: Phase 3
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The purpose of this study is to evaluate the safety and effectiveness of a once daily
controlled-release form of galantamine (a drug for treating dementia) versus placebo in the
treatment of patients with Alzheimer's disease.
Official title: Placebo-Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy of a Controlled-Release Formulation
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline to end of treatment for controlled release group in ADAS-cog/11 (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and CIBIC-plus (Clinician's Interview Based Impression of Change - Plus Caregiver Input) scores
Secondary outcome: Change from baseline in ADAS-cog/13, /10, /mem scores, NPI, and ADCS/ADL; safety and tolerability of controlled-release formulation; difference in effects between the controlled-release and immediate-release formulations
Dementia is a chronic, progressive brain disease that may involve a number of symptoms,
including memory loss and changes in personality, behavior, judgment, attention span,
language and thought. The most common type of dementia is Alzheimer's disease. Over time,
patients with Alzheimer's disease may lose the ability to perform daily tasks related to
personal care (for example, bathing, dressing, and eating) and may be unable to handle money
or travel to familiar places. Previous clinical trials have shown that a twice-daily dose of
galantamine (18 - 32 mg/day) improved symptoms of Alzheimer's disease. This multicenter,
double-blind, placebo-controlled study evaluates the safety and effectiveness of a
controlled-release form of galantamine in patients with Alzheimer's disease. All patients
receive placebo during the first month of the study. Patients then receive controlled-release
galantamine (8 - 24 mg once daily), or immediate-release galantamine (4 - 12 mg twice daily)
or placebo for 6 months. The dose of galantamine starts at 8 mg/day and may be increased up
to 24 mg/day, if needed. The dose may be adjusted up or down during the first 12 weeks of
double-blind treatment based upon effectiveness and tolerability. Patients continue to
receive the dose they are taking at the end of 12 weeks for the remainder of the study. The
primary measures of effectiveness include the change from baseline to the end of treatment in
the ADAS-cog/11 (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and
CIBIC-plus (Clinician's Interview Based Impression of Change - Plus Caregiver Input) scores.
Additional measures of effectiveness include the change from baseline in the Alzheimer's
Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and the Neuropsychiatric
Inventory (NPI) scores. Safety evaluations (incidence of adverse events, electrocardiograms
(ECGs), physical examinations, laboratory tests) are performed throughout the study. Patients
who complete the double-blind portion of the study have the opportunity to receive
galantamine in an open-label follow-up study. Patients may also participate in an optional
portion of the study in which their genetic material is analyzed to see if contains something
that would affect the way galantamine is used by their bodies. The study hypothesis is that
treatment with controlled-release galantamine is effective in improving the symptoms of
Alzheimer's disease and is well tolerated.
Controlled-release galantamine 8 - 24 mg by mouth once daily, or immediate-release
galantamine 4 - 12 mg by mouth twice daily, or placebo. Dosing starts at 8 mg/day and may be
increased up to 24 mg/day, if needed. The study duration is 6 months.
Minimum age: 40 Years.
Maximum age: N/A.
- Outpatients with a diagnosis of mild-to-moderate Alzheimer's disease according to the
National Institute of Neurological and Communicative Disorders and the Alzheimer's
Disease and Related Disorders Association (NINCDS-ADRDA) criteria (including patients
living in residential homes for the elderly or day patients)
- Have a Mini-Mental Status Examination (MMSE) score of 10 - 24, and a score of at least
18 on the cognitive portion of the Alzheimer's Disease Assessment scale (ADAS-cog-11)
with an onset between ages 40 and 90
- History of at least a 6 months of gradual and progressive cognitive decline
- Have a consistent informant to accompany the patient on scheduled visits
- Neurogenerative disorders such as Parkinson's disease
- Cognitive impairment resulting from acute cerebral trauma, cerebral damage due to a
lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant
endocrine or metabolic disease, mental retardation or a brain tumor
- Dementia caused by small strokes or cerebrovascular disease
- Having epilepsy, significant psychiatric disease, active peptic ulcer, clinically
significant liver, kidney or lung disorders, or heart disease
- Females of child bearing potential without adequate contraception
Locations and Contacts
A study of the safety and effectiveness of a controlled-release form of galantamine in patients with Alzheimer's disease
Starting date: February 2001
Ending date: July 2002
Last updated: May 11, 2007