NCT00035191

Brief Summary

This is a trial to evaluate the safety and effectiveness of galantamine in patients with dementia secondary to blood vessel disease in the brain.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
254

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2001

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

October 1, 2001

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2002

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

June 8, 2011

Status Verified

November 1, 2010

First QC Date

May 2, 2002

Last Update Submit

June 6, 2011

Conditions

Dementia, Vascular

Keywords

Dementiavascular dementiacerebral vascular disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to week 26 in Alzheimer's Disease Assessment Scale-cognitive portion (ADAS-cog)

Secondary Outcomes (1)

  • Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus) score and ADCS-ADL Inventory; neuropsychiatric inventory (NPI); in English-speaking countries only, the EXIT-25 scale.

Interventions

galantamineDRUG

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with vascular dementia per NINDS-AIREN criteria
  • Radiologic evidence of VaD on MRI
  • Clinical evidence of VaD (ie focal signs)
  • Onset of dementia between ages 40 and 90 years
  • Ability to read, write, communicate, and understand cognitive testing instructions
  • No uncontrolled medical conditions

You may not qualify if:

  • Presence of other diseases or disorders that could cause loss of mental functioning (such as trauma, cancer, infections, mental retardation)
  • Current significant cardiovascular disease that could limit the patient's ability to complete the study
  • Major psychiatric diseases
  • Peptic ulcer or significant urine outflow obstructions
  • Seizures
  • Other serious diseases
  • History of drug or alcohol abuse within the past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Dementia, VascularDementia

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular 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

May 2, 2002

First Posted

May 3, 2002

Study Start

October 1, 2001

Study Completion

September 1, 2003

Last Updated

June 8, 2011

Record last verified: 2010-11