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| Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00035191 |
Purpose
This is a trial to evaluate the safety and effectiveness of galantamine in patients with dementia secondary to blood vessel disease in the brain.
| Condition | Intervention | Phase |
|---|---|---|
|
Dementia, Vascular |
Drug: galantamine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized 26-Week, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Vascular Dementia |
| Estimated Enrollment: | 780 |
| Estimated Study Completion Date: | September 2003 |
In a previous 6-month study in patients with both vascular dementia and Alzheimer's dementia, galantamine demonstrated positive results on thinking, functioning, behavior, speech and overall well being of patients, and prevented the behavior symptoms of dementia from appearing. This combined study consists of two almost identical 26-week studies that examine the same criteria as the previous study, but in a larger patient population (dementia has been identified as having been caused by blood vessel disease without Alzheimer's disease). The study starts with a 4-week period in which current medications for dementia are withdrawn followed by a 26-week double-blind treatment period when patients will receive either placebo or galantamine 8 milligrams or 12 milligrams twice a day. Effectiveness will be measured by changes in scores on the Alzheimer's Disease Assessment Scale cognitive subscale, Alzheimer's Disease Cooperative Study Scale, the Clinician's Interview-Based Impression of Change Plus, and the neuropsychiatric inventory, as well as (in English-speaking countries only) a 10-minute interview of the patient (EXIT-25 scale). Safety will be evaluated throughout the study based on the incidence and severity of unexpected events, laboratory and physical tests, and vital signs. The hypothesis of the study is that galantamine will improve thinking, function, behavior, speech, and overall well being, better than placebo.
A voluntary pharmacogenomic study will be incorporated into the study plan to evaluate whether specific genes are related to the dementia or drug response.
8 milligrams (mg) 2 times a day for 8 weeks, then increasing to12 mg, if tolerated. After 12 weeks dose can be reduced to 8 mg or matching placebo
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Diagnosed with vascular dementia per NINDS-AIREN criteria - Radiologic evidence of VaD on MRI - Clinical evidence of VaD (ie focal signs) - Onset of dementia between ages 40 and 90 years - Ability to read, write, communicate, and understand cognitive testing instructions - No uncontrolled medical conditions
Exclusion Criteria: - Presence of other diseases or disorders that could cause loss of mental functioning (such as truama, cancer, infections, mental retardation) - Current signifcant cardiovascular disease that could limit the patient's ability to complete the study - Major psychiatric diseases - Peptic ulcer or significant urine outflow obstructions - Seizures - Other serious diseases - History of drug or alcohol abuse within the past year
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| Study ID Numbers: | CR002011 |
| Study First Received: | May 2, 2002 |
| Last Updated: | March 14, 2007 |
| ClinicalTrials.gov Identifier: | NCT00035191 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
vascular dementia cerebral vascular disease Dementia |
|
Arterial Occlusive Diseases Nootropic Agents Neurotransmitter Agents Galantamine Vascular Diseases Central Nervous System Diseases Arteriosclerosis Cholinergic Agents Brain Diseases Cerebrovascular Disorders |
Intracranial Arterial Diseases Cognition Disorders Cholinesterase Inhibitors Intracranial Arteriosclerosis Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia, Vascular Peripheral Nervous System Agents Dementia Delirium |
|
Parasympathomimetics Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Arteriosclerosis Brain Diseases Cholinergic Agents Intracranial Arterial Diseases Cerebrovascular Disorders Intracranial Arteriosclerosis Mental Disorders Therapeutic Uses Dementia, Vascular Cardiovascular Diseases |
Dementia Arterial Occlusive Diseases Nootropic Agents Galantamine Nervous System Diseases Vascular Diseases Central Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |
