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Trial registered on ANZCTR


Registration number
ACTRN12610000653066
Ethics application status
Approved
Date submitted
5/08/2010
Date registered
11/08/2010
Date last updated
15/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomized Clinical Trial of Cognitive Activity for the Treatment of Older Adults with Mild Alzheimer's Disease
Scientific title
A Randomized Clinical Trial of Cognitive Activity for the Treatment of Older Adults with Mild Alzheimer's Disease
Secondary ID [1] 252386 0
N/A
Universal Trial Number (UTN)
Trial acronym
PACE-AD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's disease 257899 0
Condition category
Condition code
Neurological 258059 258059 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with mild Alzheimer's disease (AD) and their companion are randomized to participate in a 12-week program of cognitive activity/stimulation. The sessions focus on different aspects of cognition, learning how these domains are altered in AD and incorporating pencil and paper tasks to demonstrate ways to enhance these areas of thinking. Seven weeks of the program (1x 90-minute session per week) are completed in a group setting with a facilitator. The additional sessions are completed at home, with participants provided with materials to complete the set material. Telephone contact is made during the week to address any concerns/questions participants may have. Dyads (participants with AD and their companion) randomized to Arm 1 will attend the sessions together.
Intervention code [1] 256949 0
Treatment: Other
Comparator / control treatment
In Arm 2, only the companion will attend all of the cognitive activity/stimulation group sessions.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258921 0
Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)

Global measure of cognition.
Timepoint [1] 258921 0
Baseline, Post Intervention and Six month follow up
Secondary outcome [1] 265087 0
Mini Mental State Examination (MMSE)

Global measure of cognition.
Timepoint [1] 265087 0
Baseline, Post Intervention and Six month follow up
Secondary outcome [2] 265088 0
Rivermead Behavioural Memory Test (RBMT)

Comprises a series of different memory tasks analogous to those faced in everyday situations.
Timepoint [2] 265088 0
Baseline, Post Intervention and Six month follow up
Secondary outcome [3] 265089 0
Verbal Fluency

Requires participants to generate words beginning with a give letter over a 60 second period.
Timepoint [3] 265089 0
Baseline, Post Intervention and Six month follow up
Secondary outcome [4] 265090 0
Tower of London

A test of spatial planning and working memory.
Timepoint [4] 265090 0
Baseline, Post Intervention and Six month follow up
Secondary outcome [5] 265091 0
Quality of Life in Alzheimer's disease (QoL-AD)

13-item questionnaire assessing perceptions of current quality of life across a number of different domains.
Timepoint [5] 265091 0
Baseline, Post Intervention and Six month follow up
Secondary outcome [6] 265092 0
Katz Instrumental activities of daily living (IADL) scale

A self report measure of range of independent activities of daily living.
Timepoint [6] 265092 0
Baseline, Post Intervention and Six month follow up
Secondary outcome [7] 265093 0
Modified Short Form of the Informant Questionnaire on Cognitive Decline in the Elderly (Short Form-IQ Code)

Self report measures assessing perception of cognitive functioning.
Timepoint [7] 265093 0
Baseline, Post Intervention and Six month follow up

Eligibility
Key inclusion criteria
Diagnosis of AD (probable or possible) according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer's criteria;
MMSE score ranging from 18-26;
Fluent in written and spoken English;
Able and willing to travel to Mercy Hospital, Mt. Lawley;
Available carer/companion who is willing to participate.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe hearing and/or visual impairment;
A diagnosis of a current acute psychiatric disorder;
Unstable of life threatening medical condition;
Current history of hazardous alcohol consumption;
Stroke associated with permanent disability;
Unable to commit for the entire six month period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation was undertaken in random
blocks of 6 to 10, with three to five dyads allocated
to each group. The allocation list was handled by an independent investigator who had no contact with
study participants and was not involved in the supervision
of staff responsible for the collection of data. The allocation
table was then passed on to the investigator running
the intervention, who invited eligible participants to
join the relevant groups. Research assistants undertaking
the follow-up assessments remained blinded to group
allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257407 0
Charities/Societies/Foundations
Name [1] 257407 0
ANZ Trustees Limited
Country [1] 257407 0
Australia
Funding source category [2] 257408 0
Charities/Societies/Foundations
Name [2] 257408 0
ANZ Trustees Limited
Country [2] 257408 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Bell Research Fellowship for Health and Ageing
Address
GPO Box 389 Melbourne Vic 3001
Country
Australia
Secondary sponsor category [1] 256636 0
None
Name [1] 256636 0
Address [1] 256636 0
Country [1] 256636 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259430 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 259430 0
Ethics committee country [1] 259430 0
Australia
Date submitted for ethics approval [1] 259430 0
Approval date [1] 259430 0
Ethics approval number [1] 259430 0
Ethics committee name [2] 259431 0
Mercy Hospital Human Research Ethics Committee
Ethics committee address [2] 259431 0
Ethics committee country [2] 259431 0
Australia
Date submitted for ethics approval [2] 259431 0
Approval date [2] 259431 0
Ethics approval number [2] 259431 0

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

Contacts
Principal investigator
Name 31482 0
Address 31482 0
Country 31482 0
Phone 31482 0
Fax 31482 0
Email 31482 0
Contact person for public queries
Name 14729 0
Mandy Vidovich
Address 14729 0
Western Australia Centre for Health and Ageing (WACHA)
Level 6 Ainslie House
48 Murray Street
Perth WA 6000
Country 14729 0
Australia
Phone 14729 0
+61 08 9224 2855
Fax 14729 0
Email 14729 0
vidovichm@meddent.uwa.edu.au
Contact person for scientific queries
Name 5657 0
Mandy Vidovich
Address 5657 0
Western Australia Centre for Health and Ageing (WACHA)
Level 6 Ainslie House
48 Murray Street
Perth WA 6000
Country 5657 0
Australia
Phone 5657 0
+61 08 9224 2855
Fax 5657 0
Email 5657 0
vidovichm@meddent.uwa.edu.au

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.