NCT00338117

Brief Summary

The purpose of this study was to determine the safety and effectiveness of a relatively high dose of galantamine, 32 mg /day in a three-times daily dosage, compared with placebo in treating patients with Alzheimer's disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
554

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 1995

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

August 1, 1995

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1997

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
Last Updated

April 28, 2010

Status Verified

April 1, 2010

First QC Date

June 16, 2006

Last Update Submit

April 26, 2010

Conditions

Alzheimer's DiseaseDementia

Keywords

Dementianeurodegenerative disorderimpairment of memorygalantaminegalanthamineacetylcholinesterase inhibitorMini Mental State Examination score

Outcome Measures

Primary Outcomes (1)

  • The primary outcomes included evaluations by EURO-ADAS cognitive score, CIBIC Plus, and NOSGER at 6 months.

Secondary Outcomes (1)

  • EURO-ADAS non-cognitive score; MMSE; Short Cognitive Performance Test (SKT) sub-set 6; Neuropsychological Assessment Battery (NAB); incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-lead ECG.

Interventions

Galantamine hydrobromideDRUG

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have been meeting the diagnostic criteria of Alzheimer's disease
  • mild or moderate dementia as measured by the Mini Mental State Examination (MMSE) score
  • live with or have daily visits from a responsible caregiver.

You may not qualify if:

  • Parkinson's disease
  • Pick's disease
  • secondary or pseudodementias
  • currently diagnosed epilepsy
  • history of endocrine disorder
  • significant heart disease
  • drug or alcohol abuse
  • kidney or liver dysfunction
  • women of child-bearing potential unless appropriate birth-control method is used
  • sensitivity to the study drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer DiseaseDementiaNeurodegenerative Diseases

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurocognitive 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

June 16, 2006

First Posted

June 20, 2006

Study Start

August 1, 1995

Study Completion

May 1, 1997

Last Updated

April 28, 2010

Record last verified: 2010-04