A Study of the Safety and Effectiveness of Galantamine Versus Placebo in the Treatment of Patients With Vascular Dementia or Mixed Dementia

NCT00261573 | Completed Phase 3

• 1 other identifier: CR006034
• Study Type: interventional
• Target: 593
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of galantamine (a drug for treating dementia) compared to placebo in the treatment of patients with dementia related to cerebrovascular disease (vascular dementia) or dementia related to Alzheimer's disease with cerebrovascular disease ("mixed" dementia).

Conditions

Alzheimer Disease; Vascular Dementia

Keywords

Alzheimer's disease with cerebrovascular disease ("mixed" dementia); probable vascular dementia; galantamine

Outcome Measures

Primary Outcomes (1)

• Change from baseline to end of double-blind 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 to the end of double-blind treatment in ADAS-cog/13, NPI, and DAD scores; Change in ADAS scores from baseline to end of open-label treatment; Incidence of adverse events; Changes in laboratory tests, ECGs and physical examinations

Interventions

galantamine hydrobromide DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients with a diagnosis of vascular dementia according to the NINDS-AIREN International Workshop criteria or with a diagnosis of "mixed" dementia (possible Alzheimer's disease with cerebrovascular disease) according to the NINCDS-ADRDA criteria
• mild-to-moderate dementia (score of 10 - 25 on the Mini Mental Status Exam (MMSE) and ADAS-cog score of at least 12)
• having the opportunity to perform activities of daily living (such as dressing, bathing, etc), including patients living independently in residential homes for the elderly
• had onset of disease between ages 40 - 90
• have a consistent informant to accompany them on scheduled visits

You may not qualify if:

• Neurogenerative disorders such as Parkinson's disease
• cognitive impairment resulting from conditions such as 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 significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney or lung disorders, or heart disease
• history of epilepsy, convulsions, drug abuse or alcohol abuse
• females of child bearing potential without adequate contraception

Sponsors & Collaborators

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

Related Publications (2)

• Erkinjuntti T, Kurz A, Gauthier S, Bullock R, Lilienfeld S, Damaraju CV. Efficacy of galantamine in probable vascular dementia and Alzheimer's disease combined with cerebrovascular disease: a randomised trial. Lancet. 2002 Apr 13;359(9314):1283-90. doi: 10.1016/S0140-6736(02)08267-3.

  PMID: 11965273 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 galantamine in patients with dementia

MeSH Terms

Conditions

Alzheimer Disease; Dementia, Vascular; Mixed Dementias

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

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: December 2, 2005
• First Posted: December 5, 2005
• Study Start: December 1, 1998
• Study Completion: December 1, 2000
• Last Updated: May 18, 2011

Record last verified: 2010-11