A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236574
First received: October 7, 2005
Last updated: June 6, 2011
Last verified: November 2010
  Purpose

The purpose of this study is to evaluate the efficacy and safety of galantamine treatment in patients with mild cognitive impairment.


Condition Intervention Phase
Dementia
Alzheimer Disease
Drug: Galantamine hydrobromide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Double Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment (MCI) Clinically at Risk for Development of Clinically Probable Alzheimer's Disease.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Memory and cognition (ADAS-cog/MCI and CDR-SB scores) at 12 months and Global functional skills and the overall severity of dementia (the CDR-SB and the overall CDR) at 24 months.

Secondary Outcome Measures:
  • Brain atrophy assessed by MRI, Digit Symbol Coding, Alzheimer's Disease Cooperative Study-ADL scale(MCI version) at 24 months. Safety evaluations (adverse event reports, vital signs, laboratory tests, physical examination, electrocardiograms) throughout.

Enrollment: 974
Study Start Date: May 2001
Study Completion Date: November 2003
Detailed Description:

This is an international, multicenter, double-blind, randomized, placebo-controlled trial. Following a 4 week screening period, patients with mild cognitive impairment (MCI), who are clinically at risk for development of Alzheimer's disease, will be randomized to treatment with either placebo or galantamine for 24 months with either placebo or a flexible dose of galantamine. Efficacy will be evaluated by measures of memory and cognition (Alzheimer's Disease Assessment Scale of cognition for MCI [ADAS-cog/MCI] and the Clinical Dementia Rating Sum of the Boxes [CDR-SB]), global severity of dementia (Clinical Dementia Rating [CDR]), functionality (Alzheimer's Disease Cooperative Study - Activities of Daily Living adapted to MCI [ADCS-ADL/MCI]), and changes on serial magnetic resonance imaging (MRI). Safety will be assessed using adverse event reports, vital signs, laboratory parameters, physical examination and electrocardiograms. The primary study hypothesis is that galantamine will improve memory deficits associated with mild cognitive impairment and therefore improve or stabilize the patient's cognitive abilities. A second study hypothesis is that treatment with galantamine slows or delays conversion of mild cognitive impairment to the dementia often associated with probable Alzheimer's disease in these patients. The third study hypothesis is that the treatment will be well tolerated by the patients. Galantamine hydrobromide immediate-release tablets (4, 8, and 12 milligrams (mg)) taken by mouth 2 times daily: 4 weeks at 8mg/day, 4 weeks at 16mg/day, increased to 24mg/day for the remainder of the 24-month trial. Dose may be reduced at investigator's discretion after 12 weeks.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical decline of cognitive ability consistent with mild cognitive impairment
  • Delayed recall score less than or equal to 10 on New York University paragraph recall test
  • Sufficient visual, hearing and communication capabilities and willingness to complete serial standard tests of cognitive function
  • Have a consistent informant to accompany them on scheduled visits
  • Be able to read, write and fully understand the language of the cognitive scales used in the study

Exclusion Criteria:

  • Contraindications for magnetic resonance imaging, for example, presence of pacemaker or presence of metal in high risk areas
  • Neurodegenerative disorders such as Parkinson's disease
  • Cognitive impairment resulting from acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency states, infections such as meningitis or AIDS, or primary of metastatic cerebral neoplasia
  • Significant endocrine or metabolic disease
  • Mental retardation
  • Women who are pregnant, nursing, or lacking adequate contraception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236574

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

Additional Information:
No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00236574     History of Changes
Other Study ID Numbers: CR003145
Study First Received: October 7, 2005
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Dementia
Alzheimer disease
Mild cognitive impairment
Galantamine hydrobromide
Memory disorder

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 25, 2014