- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00216502
A Study of the Safety and Effectiveness of Galantamine in Patients With Alzheimer's Disease
January 20, 2011 updated by: Janssen-Cilag S.p.A.
Long Term Treatment With Galantamine In Dementia
The purpose of this study is to evaluate the long-term efficacy and safety of galantamine in patients with Alzheimer's disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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 ability to perform daily tasks related to personal care (for example bathing, dressing, eating) and may be unable to handle money or travel to familiar places.
Previous short-term studies have shown galantamine to be safe and effective in treating patients with Alzheimer's disease, however the long-term safety and effectiveness of galantamine have not been examined.
This multicenter, randomized study will assess whether long-term treatment with galantamine will delay the onset of symptoms associated with Alzheimer's disease and examine the safety and effectiveness of long-term treatment with galantamine.
Patients will receive 12 months of open-label treatment with galantamine, followed by 24 months of double-blind treatment with galantamine or placebo.
Safety evaluations (incidence of adverse events, physical examinations, 12 lead ECGs, vital signs, laboratory tests) will be performed throughout the study.
Effectiveness will be determined using standard tests and rating scales to assess mental status, functioning, thinking, behavior, judgment and language (Mini Mental Status Exam [MMSE], Alzheimer's Disease Assessment Scale [ADAS-cog]; Disability Assessment for Dementia [DAD], and Clinician's Interview Based Impression of Changes plus Family Input [CIBIC-plus]).
After the first 4 weeks, assessments will be performed every 3 months during the open-label phase (first 12 months) and then every 6 months during the double-blind phase (13-36 months).
Patients whose symptoms worsen as defined by an increase of > or = to 4 points in their ADAS-cog score from the start of the double-blind phase will be withdrawn from the study.
The study hypothesis is that long-term treatment with galantamine will be effective in delaying the cognitive deterioration in patients with Alzheimer's disease and that galantamine is well-tolerated with long term treatment.
Galantamine 4 milligrams twice daily by mouth for 4 weeks, then 8 milligrams twice daily for 48 weeks.
Thereafter, galantamine will be given as 8 milligrams twice daily for an additional 24 months.
Study Type
Interventional
Enrollment (Actual)
254
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of probable Alzheimer's disease according to accepted medical standards
- Patients with mild to moderate impairment of thinking, reasoning, and judgment as defined by a score from 11-24 on the Mini Mental Status Exam (MMSE, a standard assessment tool for Alzheimer's disease) Female patients must be post-menopausal
- Patients and their caregivers must have signed informed consent forms Exclusion Criteria:
- Patients with a diagnosis of Parkinson's Disease, Pick's Disease, Huntington's Chorea, Creutzfeld-Jacob disease, Down's syndrome, brain cancer, mental retardation, epilepsy, psychiatric disease, liver, kidney or heart failure, significant heart, lung, digestive, hormone or mental disease or Vitamin B deficiency
- Patients with previous severe head injury or blood clot in the brain
- Patients who are hospitalized, living in nursing homes or residential care facilities
- Patients with brain infections such as abscess, meningitis, encephalitis
- Patients with a history of drug or alcohol abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Time to worsening of symptoms, defined as the time from the beginning of the double-blind portion of the study to the time of an increase in ADAS-cog score of > or = to 4 points
|
Secondary Outcome Measures
Outcome Measure |
---|
Change in ADAS-cog, CIBIC-plus and DAD scores over time; Safety parameters assessed by adverse events; laboratory tests, vital signs, weight and ECGs.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Janssen-Cilag S.p.A. Clinical Trial, Janssen-Cilag S.p.A.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2001
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
January 24, 2011
Last Update Submitted That Met QC Criteria
January 20, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Tauopathies
- Mental Disorders
- Dementia
- Alzheimer Disease
- Brain Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Parasympathomimetics
- Galantamine
Other Study ID Numbers
- CR004996
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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