A Study of the Safety and Effectiveness of a Flexible Dose of Galantamine Versus Placebo in the Treatment of Patients With Alzheimer's Disease

NCT00253227 | Completed Phase 3

• 1 other identifier: CR006028
• Study Type: interventional
• Target: 387
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of galantamine (a drug for treating dementia) versus placebo in the treatment of patients with Alzheimer's disease using a flexible dose design.

Conditions

Alzheimer Disease; Dementia

Keywords

Alzheimer's disease; dementia; brain disease; memory loss; galantamine; placebo

Outcome Measures

Primary Outcomes (1)

• Change from baseline to the end of treatment in ADAS-cog/11 (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and CIBIC-plus (Clinician's Interview Based Impression of Change - Plus Caregiver Input) scores

Secondary Outcomes (1)

• Change from baseline in ADAS-cog/13, DAD and NPI scores to the end of treatment; Incidence of adverse events; Pittsburgh Sleep Scale score; Changes in laboratory tests, ECGs and physical examinations

Interventions

galantamine hydrobromide DRUG

Eligibility Criteria

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

You may qualify if:

• Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria (including patients living independently in residential homes for the elderly or day patients)
• have mild to moderate dementia, as evidenced by a, Mini-Mental Status Examination (MMSE) score of 11 - 24, and a score of at least 12 on the cognitive portion of the Alzheimer's Disease Assessment scale (ADAS-cog)
• history of at least 6 months of gradual and progressive cognitive decline
• have a consistent informant to accompany the patient on scheduled visits

You may not qualify if:

• Neurogenerative disorders such as Parkinson's disease
• dementia caused by small strokes or cerebrovascular disease
• cognitive impairment resulting from acute cerebral trauma, cerebral damage due to a lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation or a brain tumor
• having epilepsy, significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney or lung disorders or heart disease
• Females of child bearing potential without adequate contraception

Sponsors & Collaborators

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

Related Publications (2)

• Rockwood K, Mintzer J, Truyen L, Wessel T, Wilkinson D. Effects of a flexible galantamine dose in Alzheimer's disease: a randomised, controlled trial. J Neurol Neurosurg Psychiatry. 2001 Nov;71(5):589-95. doi: 10.1136/jnnp.71.5.589.

  PMID: 11606667 RESULT

• Lim AWY, Schneider L, Loy C. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD001747. doi: 10.1002/14651858.CD001747.pub4.

  PMID: 39498781 DERIVED

Related Links

• A study of the safety and effectiveness of a flexible dose of galantamine in patients with Alzheimer's disease

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Brain Diseases; Memory Disorders

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; 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: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 10, 2005
• First Posted: November 15, 2005
• Study Start: July 1, 1997
• Study Completion: December 1, 1998
• Last Updated: May 18, 2011

Record last verified: 2010-11