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Cognitive activity for the treatment of older adults with mild Alzheimer's disease (AD)--PACE AD: study protocol for a randomised controlled trial.

Abstract

BACKGROUND

Participation in cognitive stimulation therapy (CST) may reduce the rate of cognitive decline in people with Alzheimer's disease (AD), however it is unclear if the training of carers to deliver activities is sufficient to improve the clinical outcome of patients. The Promoting Healthy Ageing with Cognitive Exercise for Alzheimer's Disease (PACE-AD) study has been designed to determine if change in cognitive function over a six month period can be achieved with participation in cognitive stimulating activities when the intervention is delivered to carers only as opposed to carers and patients.

METHODS/DESIGN

The study will aim to recruit 128 community-dwelling men and women with probable AD according to NINCDS-ADRDS criteria. Participants will be randomly allocated to one of two cognitive activity treatment groups: (1) Participants with mild AD and their companions together (2) Companions of participants with mild AD alone. The intervention will consist of a twelve-week program of cognitive stimulation. Seven weeks of the program will involve 90-minute group sessions delivered once per week while the remaining weeks of the program will involve structured home based activities with telephone support. The primary outcome measure of the study is the change from baseline in the total score on the Alzheimer Disease Assessment Scale-Cognitive (ADAS-COG). Secondary outcomes of interest include changes in health related quality of life, mood, memory, language, executive functions, independent living abilities and psychiatric symptoms for participants with mild AD. Changes in companion quality of life, mood, and general health will also be monitored. Primary endpoints will be collected 13 and 26 weeks after the baseline assessment.

DISCUSSION

The proposed project will provide evidence as to whether CST for people with AD and their companions is more beneficial than when used for companions alone. Outcomes sought include a reduction of further cognitive decline and improved quality of life amongst older adults with mild AD. We anticipate that the results of this study will have implications for the development of cost-effective evidence-based best practice to treat people with mild AD.

TRIAL REGISTRATION

ACTRN12610000653066.

Links

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  • Authors+Show Affiliations

    ,

    Western Australia Centre for Health and Ageing (WACHA), School of Psychiatry and Clinical Neurosciences & Centre for Medical Research, University of Western Australia and Royal Perth Hospital, Australia. vidovichm@meddent.uwa.edu.au

    , ,

    Source

    Trials 12: 2011 Feb 17 pg 47

    MeSH

    Activities of Daily Living
    Affect
    Alzheimer Disease
    Caregivers
    Cognition
    Cognitive Behavioral Therapy
    Executive Function
    Female
    Humans
    Language
    Male
    Memory
    Neuropsychological Tests
    Psychiatric Status Rating Scales
    Quality of Life
    Research Design
    Severity of Illness Index
    Single-Blind Method
    Time Factors
    Treatment Outcome
    Western Australia

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    21329501

    Citation

    Vidovich, Mandy R., et al. "Cognitive Activity for the Treatment of Older Adults With Mild Alzheimer's Disease (AD)--PACE AD: Study Protocol for a Randomised Controlled Trial." Trials, vol. 12, 2011, p. 47.
    Vidovich MR, Shaw J, Flicker L, et al. Cognitive activity for the treatment of older adults with mild Alzheimer's disease (AD)--PACE AD: study protocol for a randomised controlled trial. Trials. 2011;12:47.
    Vidovich, M. R., Shaw, J., Flicker, L., & Almeida, O. P. (2011). Cognitive activity for the treatment of older adults with mild Alzheimer's disease (AD)--PACE AD: study protocol for a randomised controlled trial. Trials, 12, p. 47. doi:10.1186/1745-6215-12-47.
    Vidovich MR, et al. Cognitive Activity for the Treatment of Older Adults With Mild Alzheimer's Disease (AD)--PACE AD: Study Protocol for a Randomised Controlled Trial. Trials. 2011 Feb 17;12:47. PubMed PMID: 21329501.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Cognitive activity for the treatment of older adults with mild Alzheimer's disease (AD)--PACE AD: study protocol for a randomised controlled trial. AU - Vidovich,Mandy R, AU - Shaw,Josephine, AU - Flicker,Leon, AU - Almeida,Osvaldo P, Y1 - 2011/02/17/ PY - 2010/12/23/received PY - 2011/02/17/accepted PY - 2011/2/19/entrez PY - 2011/2/19/pubmed PY - 2011/6/29/medline SP - 47 EP - 47 JF - Trials JO - Trials VL - 12 N2 - BACKGROUND: Participation in cognitive stimulation therapy (CST) may reduce the rate of cognitive decline in people with Alzheimer's disease (AD), however it is unclear if the training of carers to deliver activities is sufficient to improve the clinical outcome of patients. The Promoting Healthy Ageing with Cognitive Exercise for Alzheimer's Disease (PACE-AD) study has been designed to determine if change in cognitive function over a six month period can be achieved with participation in cognitive stimulating activities when the intervention is delivered to carers only as opposed to carers and patients. METHODS/DESIGN: The study will aim to recruit 128 community-dwelling men and women with probable AD according to NINCDS-ADRDS criteria. Participants will be randomly allocated to one of two cognitive activity treatment groups: (1) Participants with mild AD and their companions together (2) Companions of participants with mild AD alone. The intervention will consist of a twelve-week program of cognitive stimulation. Seven weeks of the program will involve 90-minute group sessions delivered once per week while the remaining weeks of the program will involve structured home based activities with telephone support. The primary outcome measure of the study is the change from baseline in the total score on the Alzheimer Disease Assessment Scale-Cognitive (ADAS-COG). Secondary outcomes of interest include changes in health related quality of life, mood, memory, language, executive functions, independent living abilities and psychiatric symptoms for participants with mild AD. Changes in companion quality of life, mood, and general health will also be monitored. Primary endpoints will be collected 13 and 26 weeks after the baseline assessment. DISCUSSION: The proposed project will provide evidence as to whether CST for people with AD and their companions is more beneficial than when used for companions alone. Outcomes sought include a reduction of further cognitive decline and improved quality of life amongst older adults with mild AD. We anticipate that the results of this study will have implications for the development of cost-effective evidence-based best practice to treat people with mild AD. TRIAL REGISTRATION: ACTRN12610000653066. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/21329501/Cognitive_activity_for_the_treatment_of_older_adults_with_mild_Alzheimer's_disease__AD___PACE_AD:_study_protocol_for_a_randomised_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-12-47 DB - PRIME DP - Unbound Medicine ER -