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

NCT00240695 | Completed Phase 3

• 1 other identifier: CR005947
• Study Type: interventional
• Target: 724
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Cognition Disorder; Nervous System Diseases; Mental Disorders; Brain Diseases

Keywords

Alzheimer's disease; Dementia; Brain Disease; Memory Loss; galantamine; Nervous System Diseases; open-label; elderly

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events; Changes in laboratory tests, ECGs, and physical examinations

Secondary Outcomes (1)

• 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

Interventions

galantamine hydrobromide DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

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

MeSH Terms

Conditions

Cognition Disorders; Nervous System Diseases; Mental Disorders; Brain Diseases; Alzheimer Disease; Dementia; Memory Disorders

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: May 1, 2003
• Study Completion: May 1, 2004
• Last Updated: May 18, 2011

Record last verified: 2010-04