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

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ClinicalTrials.gov Identifier: NCT00035191
Recruitment Status : Completed
First Posted : May 3, 2002
Last Update Posted : June 8, 2011
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary:
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 or disease Intervention/treatment Phase
Dementia, Vascular Drug: galantamine Phase 3

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 The study starts with a 4-week period in which current medications for dementia are withdrawn followed by a 26-week double-blind treatment period when patients will receive either placebo or galantamine 8 milligrams or 12 milligrams twice a day.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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : October 2001
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 trauma, cancer, infections, mental retardation)
  • Current significant 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

Information from the National Library of Medicine

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): NCT00035191

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Additional Information:
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ClinicalTrials.gov Identifier: NCT00035191    
Other Study ID Numbers: CR002011
First Posted: May 3, 2002    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: November 2010
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
vascular dementia
cerebral vascular disease
Additional relevant MeSH terms:
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Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents