Condition category
Nervous System Diseases
Date applied
01/09/2005
Date assigned
01/09/2005
Last edited
03/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kenneth Rockwood

ORCID ID

Contact details

Divisions of Geriatric Medicine and Neurology
Geriatric Medicine Research Unit
Dalhousie University/Capital Health
Suite 1421
Veterans' Memorial Building
5955 Veterans' Memorial Lane
Halifax
Nova Scotia
B3H 2E1
Canada
+1 902 473 8687
kenneth.rockwood@dal.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DCT-49981

Study information

Scientific title

Evaluating the effects of galantamine HBr using Goal Attainment Scaling (GAS) in a placebo-controlled trial of mild to moderate Alzheimer's disease subjects

Acronym

VISTA

Study hypothesis

To access the efficiency of galantamine in terms of the goals established by:
1. Patients with AD and their primary carers
2. Treating physicians

Please note that as of 03/03/2009 this record was updated; all updates can be found in the relevant field under the above update date. Please note that the actual trial dates have varied from the anticipated trial dates, the anticipated trial dates at the time of registration were:
Initial anticipated start date: 01/07/2001
Initial anticipated end date: 30/06/2003

At this time, the acronym was changed from 'GAS' to 'VISTA', and the public title was added as above. The original public title has been moved to the scientific title field as this is more appropriate.

Ethics approval

Added 03/03/2009: Queen Elizabeth II Health Sciences Centre (now Capital Health) Research Ethics Board (Canada) approved on 9th October 2001

Study design

Multi-centre, randomised, double-blind, placebo-controlled trial, followed by an open-label phase

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Alzheimer’s disease (AD)

Intervention

Added as of 03/03/2009:
Galantamine group:
1. Placebo-controlled phase: galantamine 4 mg twice daily (b.i.d.) for 4 weeks, followed by galantamine 8 mg b.i.d. for 4 weeks (end of week 8), followed by galantamine flexibly dosed at 8 - 12 mg b.i.d. for 8 weeks (end of week 16)
2. Open-label phase: galantamine 8-12 mg b.i.d. for 16 weeks (end of week 32)

Control group:
1. Placebo-controlled phase: placebo matched to galantamine 4, 8 and 12 mg twice daily for 16 weeks
2. Open-label phase: galantamine 4 mg b.i.d. for 4 weeks (end of week 20), followed by galantamine 8 mg b.i.d. for 4 weeks (end of week 24), followed by galantamine flexibly dosed at 8 - 12 mg b.i.d. for 8 weeks (end of week 32)

Initial information at time of registration:
Intervention: Flexible dosed galantamine (16 - 24 mg/day) in mild to moderate AD patients, with 16 week open label follow-up
Control: Placebo

Intervention type

Drug

Phase

Not Applicable

Drug names

Galantamine

Primary outcome measures

Goal Attainment Scaling (GAS) Score at 16 weeks

Secondary outcome measures

Measured at 16 weeks:
1. Alzheimer's Disease Assessment Scale – Cognitive Subscale (ADAS-Cog)
2. Clinicians' Interview-Based Impression of Change-Plus Caregiver Input (CIBIC-Plus)
3. Disability Assessment for Dementia (DAD)
4. Caregiver Burden Scale (CBS)

The following were exploratory outcomes:
Red Pen Task, Examination of Memory and Temporality, Allocation of Caregiving Time Survey

Overall trial start date

29/10/2001

Overall trial end date

09/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent
2. Aged greater than or equal to 50 years old, either sex
3. Diagnostic evidence of mild to moderate AD consistent with the national institute of neurological communicative disorders and the Alzheimer’s disease and related disorders association (NINCDS-ADRDA)
4. A history of cognitive decline that has been gradual in onset and progressive over a period of at least 6 months
5. A reliable carer
6. A mini-mental state examination (MMSE) score of 10-25 inclusive at screening
7. An Alzheimer’s disease assessment scale-cognitive section (ADAS-cog-11) score of at least 18 at screening
8. Sufficient health based upon pre-trial physical/neurological examination

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

152

Participant exclusion criteria

1. Other neurodegenerative disorders
2. Other conditions possibly resulting in cognitive impairment
3. Multi-infarct dementia or clinically active cerebrovascular disease
4. Coexisting medical conditions such as epilepsy, psychiatric disease, peptic ulcer, urinary outflow obstruction, or significant hepatic, renal, pulmonary, metabolic or endocrine disturbances
5. Clinically significant cardiovascular disease
6. Any agent used for the treatment of dementia
7.History of drug or alcohol abuse within the last year or prior prolonged history
8. Female subjects who are not surgically sterile or post menopausal
9. History of severe drug allergy or hypersensitivity

Recruitment start date

29/10/2001

Recruitment end date

09/03/2005

Locations

Countries of recruitment

Canada

Trial participating centre

Divisions of Geriatric Medicine and Neurology
Halifax, Nova Scotia
B3H 2E1
Canada

Sponsor information

Organisation

Dalhousie University (Nova Scotia) (Canada)

Sponsor details

1236 Henry Street
Halifax
Nova Scotia
B3H 3J5
Canada

Sponsor type

University/education

Website

http://www.dal.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-49981)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Janssen-Ortho Inc. (Canada) (original)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Janssen-Ortho Inc. (Canada) (supplemental funding)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in:
1. 2006: http://www.ncbi.nlm.nih.gov/pubmed/16554498
2. 2007: http://www.ncbi.nlm.nih.gov/pubmed/17404193
3. 2008: http://www.ncbi.nlm.nih.gov/pubmed/18405399

Publication citations

  1. Rockwood K, Fay S, Song X, MacKnight C, Gorman M, , Attainment of treatment goals by people with Alzheimer's disease receiving galantamine: a randomized controlled trial., CMAJ, 2006, 174, 8, 1099-1105, doi: 10.1503/cmaj.051432.

  2. Rockwood K, Fay S, Jarrett P, Asp E, Effect of galantamine on verbal repetition in AD: a secondary analysis of the VISTA trial., Neurology, 2007, 68, 14, 1116-1121, doi: 10.1212/01.wnl.0000258661.61577.b7.

  3. Cook C, Fay S, Rockwood K, Decreased initiation of usual activities in people with mild-to-moderate Alzheimer's disease: a descriptive analysis from the VISTA clinical trial., Int Psychogeriatr, 2008, 20, 5, 952-963, doi: 10.1017/S1041610208007230.

Additional files

Editorial Notes