Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001119886
Ethics application status
Approved
Date submitted
4/10/2012
Date registered
19/10/2012
Date last updated
19/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Combating dementia by cognitive enrichment
Scientific title
A randomized-controlled design to examine whether cognitive enrichment enhances the structure and function of the brain's default mode system in people showing mild cognitive impairment.
Secondary ID [1] 281339 0
Nil
Universal Trial Number (UTN)
U1111-1135-4373
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 287565 0
Alzheimer's disease 287566 0
mild cognitive impairment 287567 0
Condition category
Condition code
Neurological 287891 287891 0 0
Dementias
Mental Health 287921 287921 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive enrichment: (a) 3 or 4 x 1 hour session per week for 24 weeks (3 or 4 based on participant choice / feasibility) and (b) provided at home through a combination of support person / significant other and research psychologists, with weekly visits and telephone support (minimum of one 5 min call every fortnight, up to 20 minutes if required or weekly if required).
Intervention code [1] 285805 0
Treatment: Other
Intervention code [2] 285833 0
Prevention
Intervention code [3] 285834 0
Early detection / Screening
Comparator / control treatment
Wait-list control, offered intervention starting at 6 to 7 months after baseline assessments.
Control group
Active

Outcomes
Primary outcome [1] 288105 0
Change to the default mode system: Primary outcome variables will be fMRI functional connectivity comparisons across resting state, working memory and Self-appraisal conditions.
Timepoint [1] 288105 0
Baseline vs 6 months
Secondary outcome [1] 299433 0
Cognitive improvement, based on (a) standardized neuropsychological tests covering the domains of "executive function, attention and working memory, visuospatial function, language, and episodic memory; (b) the ADAS-Cog and DRS-2 (c) experimental tasks (Attention Network Test, Ambiguous Patterns, and Structural Learning); and (d) autobiographical and Dodson source memory.
Timepoint [1] 299433 0
1. Baseline, 8-9 weeks, 17-18 weeks and 6 months for (a) a restricted set of the neuropsychological tests (story memory, Stroop, and Symbol Digit Modalities Test) , (c) experimental tasks (Attention Network Test, Ambiguous Patterns, and Structural Learning) and (d) source memory.
2. Baseline vs 6 months for (a) standardized neuropsychological tests covering the domains of "executive function, attention and working memory, visuospatial function, language, and episodic memory; (b) the ADAS-Cog and DRS-2; and (d) autobiographical memory (autobiographical memory interview at baseline, then more detailed Test Episodique du Memoire du Passe Autobiographique at 6 months).
Secondary outcome [2] 299434 0
Improved support person well-being: Zarit Burden Inventory, 12-item Health Status Questionnaire, Geriatric Depression Scale and Geriatric Anxiety Inventory.
Timepoint [2] 299434 0
baseline vs 6 months

Eligibility
Key inclusion criteria
mild cognitive impairment: two measures reaching 1.5 SD below age and education matched normative data within any of the the domains of "executive function, attention and working memory, visuospatial function, language, and episodic memory", and without significant impairment to everyday functional activities (Reisberg IADLS).
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
dementia; current psychiatric or other medical condition affecting cognitive abilities; early developmental disorder

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer. Participant ID used in randomized allocation. Inclusion in the trial made prior to randomization. Based on an earlier screen of 550 volunteers, baseline neuropsychological testing will identify 40 individuals meeting criteria for mild cognitive impairment. These will be advised that they will receive cognitive enrichment or be wait-listed to receive cognitive enrichment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic balanced randomization to treatment or wait-list control, based on gender, baseline cognition and age.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Those in the intervention arm may or may not continue at the end of the study period. Those in the wait-list arm given the opportunity to have intervention at the end of the study period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 4583 0
New Zealand
State/province [1] 4583 0
Canterbury

Funding & Sponsors
Funding source category [1] 286105 0
Government body
Name [1] 286105 0
Lottery Health NZ
Country [1] 286105 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
New Zealand Brain Research Institute
Address
66 Stewart St.,
Christchurch 8011
Country
New Zealand
Secondary sponsor category [1] 284917 0
University
Name [1] 284917 0
University of Canterbury
Address [1] 284917 0
Department of Psychology
Ilam Rd.,
Christchurch 8084
Country [1] 284917 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288152 0
Health and Disability Ethics Committees
Ethics committee address [1] 288152 0
Ethics committee country [1] 288152 0
New Zealand
Date submitted for ethics approval [1] 288152 0
20/05/2012
Approval date [1] 288152 0
31/07/2012
Ethics approval number [1] 288152 0
URA/12/05/06

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34790 0
Address 34790 0
Country 34790 0
Phone 34790 0
Fax 34790 0
Email 34790 0
Contact person for public queries
Name 18037 0
Leslie Livingston
Address 18037 0
New Zealand Brain Research Institute
66 Stewart St.,
Christchurch 8011
Country 18037 0
New Zealand
Phone 18037 0
64 3 378 6257
Fax 18037 0
64 3 3786 299
Email 18037 0
[email protected]
Contact person for scientific queries
Name 8965 0
Assoc. Prof. John Dalrymple-Alford
Address 8965 0
New Zealand Brain Research Institute
66 Stewart St.,
Christchurch 8011
Country 8965 0
New Zealand
Phone 8965 0
64 3 378 6090
Fax 8965 0
64 3 3786 299
Email 8965 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.