A Cardiac Safety Study of Galantamine in the Treatment of Alzheimer's Disease.
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|ClinicalTrials.gov Identifier: NCT00309725|
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : May 18, 2011
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: galantamine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Placebo-Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: A Cardiac Safety Study.|
|Actual Study Completion Date :||October 1999|
- 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
- Pharmacokinetics and other safety parameters including ECG parameters were other parameters of interest.
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309725
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|
|Other Study ID Numbers:||
|First Posted:||April 3, 2006 Key Record Dates|
|Last Update Posted:||May 18, 2011|
|Last Verified:||January 2011|
Central Nervous System Diseases
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Peripheral Nervous System Agents