NCT00216502

Brief Summary

The purpose of this study is to evaluate the long-term efficacy and safety of galantamine in patients with Alzheimer's disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
254

participants targeted

Target at P25-P50 for phase_3 alzheimer-disease

Timeline
Completed

Started Aug 2001

Typical duration 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

August 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

First QC Date

September 13, 2005

Last Update Submit

January 20, 2011

Conditions

Alzheimer DiseaseDementiaMental DisordersBrain Diseases

Keywords

Alzheimer's diseaseDementiagalantamineplaceboCaregiverBrain diseaseMemory loss

Outcome Measures

Primary Outcomes (1)

  • Time to worsening of symptoms, defined as the time from the beginning of the double-blind portion of the study to the time of an increase in ADAS-cog score of > or = to 4 points

Secondary Outcomes (1)

  • Change in ADAS-cog, CIBIC-plus and DAD scores over time; Safety parameters assessed by adverse events; laboratory tests, vital signs, weight and ECGs.

Interventions

galantamine hydrobromideDRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of probable Alzheimer's disease according to accepted medical standards
  • Patients with mild to moderate impairment of thinking, reasoning, and judgment as defined by a score from 11-24 on the Mini Mental Status Exam (MMSE, a standard assessment tool for Alzheimer's disease) Female patients must be post-menopausal

You may not qualify if:

  • Patients with a diagnosis of Parkinson's Disease, Pick's Disease, Huntington's Chorea, Creutzfeld-Jacob disease, Down's syndrome, brain cancer, mental retardation, epilepsy, psychiatric disease, liver, kidney or heart failure, significant heart, lung, digestive, hormone or mental disease or Vitamin B deficiency
  • Patients with previous severe head injury or blood clot in the brain
  • Patients who are hospitalized, living in nursing homes or residential care facilities
  • Patients with brain infections such as abscess, meningitis, encephalitis
  • Patients with a history of drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer DiseaseDementiaMental DisordersBrain DiseasesMemory Disorders

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amaryllidaceae AlkaloidsAlkaloidsHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Janssen-Cilag S.p.A. Clinical Trial

    Janssen-Cilag S.p.A.

    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

September 13, 2005

First Posted

September 22, 2005

Study Start

August 1, 2001

Study Completion

November 1, 2005

Last Updated

January 24, 2011

Record last verified: 2011-01