The Video Imaging Synthesis of Treating Alzheimer's disease study
| ISRCTN | ISRCTN26167328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26167328 |
| Secondary identifying numbers | DCT-49981 |
- Submission date
- 01/09/2005
- Registration date
- 01/09/2005
- Last edited
- 02/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Kenneth Rockwood
Scientific
Scientific
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
| Phone | +1 902 473 8687 |
|---|---|
| kenneth.rockwood@dal.ca |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study acronym | VISTA |
| Study objectives | 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(s) | Added 03/03/2009: Queen Elizabeth II Health Sciences Centre (now Capital Health) Research Ethics Board (Canada) approved on 9th October 2001 |
| Health condition(s) or problem(s) studied | Alzheimers 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Galantamine |
| Primary outcome measure | 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 study start date | 29/10/2001 |
| Completion date | 09/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 152 |
| Total final enrolment | 130 |
| Key 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 Alzheimers 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 Alzheimers 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 |
| Key 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 |
| Date of first enrolment | 29/10/2001 |
| Date of final enrolment | 09/03/2005 |
Locations
Countries of recruitment
- Canada
Study participating centre
Divisions of Geriatric Medicine and Neurology
Halifax, Nova Scotia
B3H 2E1
Canada
B3H 2E1
Canada
Sponsor information
Dalhousie University (Nova Scotia) (Canada)
University/education
University/education
1236 Henry Street
Halifax, Nova Scotia
B3H 3J5
Canada
| Website | http://www.dal.ca/ |
|---|---|
"ROR" |
https://ror.org/01e6qks80 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-49981)
No information available
Janssen-Ortho Inc. (Canada) (original)
No information available
Janssen-Ortho Inc. (Canada) (supplemental funding)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | : | 11/04/2006 | Yes | No | |
| Other publications | : | 03/04/2007 | Yes | No | |
| Other publications | : | 01/10/2008 | Yes | No | |
| Other publications | 31/03/2017 | 02/11/2022 | Yes | No |
Editorial Notes
02/11/2022: Publication reference and total final enrolment added.
