The Video Imaging Synthesis of Treating Alzheimer's disease study

ISRCTN	ISRCTN26167328
DOI	https://doi.org/10.1186/ISRCTN26167328
Protocol serial number	DCT-49981
Sponsor	Dalhousie University (Nova Scotia) (Canada)
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-49981), Janssen-Ortho Inc. (Canada) (original), Janssen-Ortho Inc. (Canada) (supplemental funding)

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

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
Email	kenneth.rockwood@dal.ca

Study information

Primary study design	Interventional
Study design	Multi-centre, randomised, double-blind, placebo-controlled trial, followed by an open-label phase
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Galantamine
Primary outcome measure(s)	Goal Attainment Scaling (GAS) Score at 16 weeks
Key secondary outcome measure(s)	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
Completion date	09/03/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.