NCT00253214

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of a once daily controlled-release form of galantamine (a drug for treating dementia) versus placebo in the treatment of patients with Alzheimer's disease.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
973

participants targeted

Target at P75+ for phase_3 alzheimer-disease

Timeline
Completed

Started Mar 2001

Shorter than P25 for phase_3 alzheimer-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
Last Updated

May 23, 2011

Status Verified

November 1, 2010

First QC Date

November 10, 2005

Last Update Submit

May 19, 2011

Conditions

Alzheimer DiseaseDementia

Keywords

Alzheimer's diseasedementiagalantamine hydrobromidecontrolled-releaseonce-daily dosing

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to end of treatment for controlled release group 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, /10, /mem scores, NPI, and ADCS/ADL; safety and tolerability of controlled-release formulation; difference in effects between the controlled-release and immediate-release formulations

Interventions

galantamine hydrobromideDRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients with a diagnosis of mild-to-moderate 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 in residential homes for the elderly or day patients)
  • have a Mini-Mental Status Examination (MMSE) score of 10 - 24, and a score of at least 18 on the cognitive portion of the Alzheimer's Disease Assessment scale (ADAS-cog-11) with an onset between ages 40 and 90
  • history of at least a 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
  • 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
  • dementia caused by small strokes or cerebrovascular disease
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Brodaty H, Corey-Bloom J, Potocnik FC, Truyen L, Gold M, Damaraju CR. Galantamine prolonged-release formulation in the treatment of mild to moderate Alzheimer's disease. Dement Geriatr Cogn Disord. 2005;20(2-3):120-32. doi: 10.1159/000086613. Epub 2005 Jun 30.

    PMID: 15990426RESULT

  • 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: 39498781DERIVED

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae AlkaloidsAlkaloidsHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic 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

March 1, 2001

Study Completion

July 1, 2002

Last Updated

May 23, 2011

Record last verified: 2010-11