- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00309725
A Cardiac Safety Study of Galantamine in the Treatment of Alzheimer's Disease.
May 17, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Placebo-Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: A Cardiac Safety Study.
The objective of this trial was to investigate the effect of galantamine (an acetylcholinesterase inhibitor) on heart rate and PR interval (the time it takes for the heart's electrical impulse to get from the atria to the ventricles) during the administration of rapidly increasing doses and at the end of a 2-week treatment period with 32 mg per day in patients with Alzheimer's disease.
Study Overview
Detailed Description
This 6-week, double-blind, parallel group trial was also designed to detect cardiac arrhythmias and conduction disturbances, such as heart block.
Holter monitors and Electrocardiograms were used to measure cardiac parameters at baseline, at the end of Week 2 (first dose of 12 mg twice daily), at the end of Week 4 (first dose of 16 mg twice daily) and at Week 6 (after 2 weeks of maximum tolerated dose allowed in the trial, i.e., 24 or 32 mg/day).
Other safety data collected were adverse event reports, urine and blood analysis, vital signs and physical examination.
Drug levels in the blood were also tested.
Patients were randomized to receive either placebo or galantamine up to 32 mg daily (i.e., 4 mg twice daily in Week 1, 8 mg twice daily in Week 2, 12 mg twice daily in Weeks 3 and 4, and 16 mg twice daily in Weeks 5 and 6).
Dosage could be reduced from 16 mg twice daily to 12 mg twice daily during the first 3 days of the 32 mg/day dosing period, if a patient could not tolerate the higher dose.
This titration is more rapid and the dose is higher than currently recommended for treatment.
Study Type
Interventional
Enrollment (Actual)
139
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Outpatients diagnosed with Alzheimer's disease in accordance with NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) classification for probable Alzheimer's disease
- Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 11 to 24, inclusive, at baseline
- History of cognitive decline that has been gradual in onset and progressive over a period of at least 6 months
- Evidence of sustained memory deterioration in an otherwise alert patient, plus additional impairment in at least one of these five areas: orientation, judgment and problem-solving, functioning in community affairs, functioning in home and hobbies, and functioning in personal care
- Patients who live with or have regular daily visits from one or more responsible caregiver who are capable of assisting with the patient's medication, able to accompany the patient for assessments, and willing to provide information about the patient.On days that the patient was sent home with a Holter monitor, the caregiver was required to stay with the patient in the same household for the 24 hour duration of the cardiac assessment to ensure that the monitor lead placement remained intact. The caregiver was to be available the following day for the return of the Holter monitoring device
- Patient or patient's relative, guardian or legal representative have signed the informed consent.
Exclusion Criteria:
- Disorders such as Parkinson's disease, Pick's disease, or Huntington's chorea, Down's syndrome, Creutzfeldt-Jakob disease, Cushing's syndrome, or uncontrolled diabetes
- Cognitive impairment resulting from trauma, injury, or hypoxia
- Infection
- Mental retardation or dementia or clinically active cerebrovascular disease
- Current, clinically significant cardiovascular disease that would limit the patient's ability to complete a six-week trial.
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 |
---|
Hourly mean heart rates and PR intervals during each of the 24-hour Holter monitoring periods; Twenty-four hour mean, minimum and maximum heart rates and PR intervals during each of the 24-hour Holter monitoring periods
|
Secondary Outcome Measures
Outcome Measure |
---|
Pharmacokinetics and other safety parameters including ECG parameters were other parameters of interest.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 Completion (Actual)
October 1, 1999
Study Registration Dates
First Submitted
March 31, 2006
First Submitted That Met QC Criteria
March 31, 2006
First Posted (Estimate)
April 3, 2006
Study Record Updates
Last Update Posted (Estimate)
May 18, 2011
Last Update Submitted That Met QC Criteria
May 17, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- 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
- CR012118
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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