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

Mental Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240695
• Other study ID #: CR005947
• Status: Completed
• Phase: Phase 3
• First received: October 14, 2005
• Last updated: May 17, 2011
• Start date: May 2003
• Est. completion date: May 2004

Study information

• Verified date: April 2010
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 724
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Cognition Disorder
• Cognition Disorders
• Disease
• Mental Disorders
• Mild Cognitive Impairment
• Nervous System Diseases
• Psychotic Disorders

Intervention

Drug:
• galantamine hydrobromide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events; Changes in laboratory tests, ECGs, and physical examinations
Secondary	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

External Links

•   A follow-up study to assess safety and tolerability of galantamine treatment in patients with mild cognitive impairment