A Follow-up Study to Assess Safety and Tolerability of Galantamine Treatment in Individuals With Mild Cognitive Impairment

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00240695
First received: October 14, 2005
Last updated: May 17, 2011
Last verified: April 2010
  Purpose

The purpose of this follow-up study is to assess the long-term safety and tolerability of galantamine in individuals with mild cognitive impairment who participated in a previous study with galantamine


Condition Intervention Phase
Cognition Disorder
Nervous System Diseases
Mental Disorders
Brain Diseases
Drug: galantamine hydrobromide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Galantamine HBr in the Treatment of Mild Cognitive Impairment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of adverse events; Changes in laboratory tests, ECGs, and physical examinations

Secondary Outcome Measures:
  • Change in CDR, ADAS-Cog/MCI version, CDR-SB and SF-36 scores from baseline to end of treatment; resource use; time to conversion to dementia

Enrollment: 724
Study Start Date: May 2003
Study Completion Date: May 2004
Detailed Description:

Dementia is a chronic, progressive brain disease that may involve a number of symptoms, including memory loss and changes in personality, behavior, judgment, attention span, language and thought. The most common type of dementia is Alzheimer's disease. Over time, patients with Alzheimer's disease may lose ability to perform daily tasks related to personal care (for example bathing, dressing, eating) and may be unable to handle money or travel to familiar places. The term mild cognitive impairment (MCI) is used to describe individuals who have memory impairments suggestive of early dementia, but do not yet meet the criteria for Alzheimer's disease. Individuals with MCI are more likely to develop Alzheimer's disease than normal elderly patients. Individuals with MCI who completed 1 of 2 previous double-blind studies with galantamine may participate in this follow-up study if they have not progressed to dementia. They will receive open-label galantamine for 12 months and will be evaluated after 2, 6 and 12 months of treatment. Safety evaluations (incidence of adverse events, ECGs, physical examinations, laboratory tests) will be performed throughout the study. Effectiveness will be assessed after 12 months of treatment (by using standardized tests and rating scales (Alzheimer's Disease Assessment Scale: cognitive/MCI version [ADAS-Cog/MCI], Clinical Dementia Rating [CDR] and CDR-Sum of the Boxes [CDR-SB]). Health status will be assessed using the Health Survey portion of the Short-Form 36 (SF-36) and the use of health and social care resources will be assessed using a resource-use questionnaire. The enrolled individuals may participate in an optional portion of the study in which their genetic material is analyzed to see if contains something that would affect the way galantamine is used by their bodies. Galantamine 8 or 12 milligrams (mg) by mouth twice daily for 12 months. Dose will start at 4 mg twice daily and be gradually increased to final dose; 12 mg twice daily dose may be decreased to 8 mg twice daily based upon tolerability

  Eligibility

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

Inclusion Criteria:

  • Completed 24 months of double-blind treatment in 1 of 2 previous studies with galantamine without progressing to dementia (CDR< 1)
  • Able to safely receive open-label galantamine in the opinion of the investigator and treatment is in the individual's best interest
  • Regular (at least 3 days a week) visits from a person able to accompany patient to scheduled visits
  • Enrolled within 7-30 days after the previous galantamine study Exclusion Criteria:
  • Individuals who converted to dementia (CDR > = 1) during 1 of the previous galantamine studies
  • Prematurely discontinued 1 of the previous galantamine studies or completed 1 of the previous studies more than 30 days prior to this study
  • Current clinically significant cardiovascular disease (including heart surgery, unstable angina, congestive heart failure, fibrillation, valve disease or uncontrolled high blood pressure)
  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: NCT00240695

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

ClinicalTrials.gov Identifier: NCT00240695     History of Changes
Other Study ID Numbers: CR005947
Study First Received: October 14, 2005
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Alzheimer's disease
Dementia
Brain Disease
Memory Loss
galantamine
Nervous System Diseases
open-label
elderly

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Brain Diseases
Cognition Disorders
Nervous System Diseases
Schizophrenia and Disorders with Psychotic Features
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Galantamine
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 22, 2014