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A Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Vascular Dementia

This study has been completed.

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

MedlinePlus related topics:   Dementia   

Drug Information available for:   Galantamine hydrobromide    Galantamine   

U.S. FDA Resources

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

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Change from baseline to week 26 in Alzheimer's Disease Assessment Scale-cognitive portion (ADAS-cog)

Secondary Outcome Measures:
  • Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus) score and ADCS-ADL Inventory; neuropsychiatric inventory (NPI); in English-speaking countries only, the EXIT-25 scale.

Estimated Enrollment:   780
Estimated Study Completion Date:   September 2003

Detailed Description:

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 The study starts with a 4-week period in which current medications for dementia are withdrawn followed by a 26-week double-blind treatment period when patients will receive either placebo or galantamine 8 milligrams or 12 milligrams twice a day.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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035191

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators
Study Director:     Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial     Johnson & Johnson Pharmaceutical Research & Development, L.L.C.    
  More Information


Placebo Controlled Trial to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Vascular Dementia  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CR002011
First Received:   May 2, 2002
Last Updated:   March 14, 2007
ClinicalTrials.gov Identifier:   NCT00035191
Health Authority:   United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
vascular dementia  
cerebral vascular disease  
Dementia  

Study placed in the following topic categories:
Arterial Occlusive Diseases
Galantamine
Vascular Diseases
Central Nervous System Diseases
Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Cognition Disorders
Intracranial Arteriosclerosis
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia, Vascular
Dementia
Delirium

Additional relevant MeSH terms:
Parasympathomimetics
Nootropic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Cholinergic Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Autonomic Agents
Therapeutic Uses
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 24, 2008




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