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ISRCTN
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ISRCTN43007027
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ClinicalTrials.gov identifier
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Public title
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Functional anatomy and impact of cognitive training on chunking within working memory in early Alzheimer's disease
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Scientific title
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Functional anatomy and impact of cognitive training on chunking within working memory in early Alzheimer's disease: a randomised controlled trial
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Acronym
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N/A
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Serial number at source
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Version 1 (13.7.10); G0901982
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Study hypothesis
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1. Training individuals with early Alzheimer's disease (AD) in the use of chunking strategies will improve their working memory (WM) capacity
2. Use of chunking strategies in early AD will correlate with significantly increased activity in the prefrontal cortex (PFC) and posterior parietal cortex (PPC)
3. Following training in chunking, improvement in WM capacity will generalise across different modalities of WM tasks and measures of general cognitive functioning
4. Improvements in WM following cognitive training will be associated with structural and functional re-organisation of brain activity
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Lay summary
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Ethics approval
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Cambridgeshire 1 Research Ethics Committee approved on the 21st October 2010 (ref: 10/H0304/68)
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Early Alzheimer's disease
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Participants - inclusion criteria
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1. Aged greater than 60 years, either sex
2. Diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
3. Mini-Mental State Examination (MMSE) score greater than 23/30
4. All subjects will be required to provide informed consent to participate in the study
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Participants - exclusion criteria
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1. Co-existent neurological or psychiatric disease
2. Substance misuse
3. Significant auditory or visual impairment
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Anticipated start date
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20/12/2010
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Anticipated end date
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05/08/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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30
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Interventions
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Subjects will be randomly allocated to either a cognitive training group or control group. The cognitive training group will undergo 18 days of training over 6 weeks for approximately 45 minutes/day. Each training session will consist of 30 trials of structured span tasks. The length of span will be adjusted after each trial depending on whether it is correctly recalled. Each subject will therefore be continually tested at their span limit, which can adjust both within and across sessions. The control group will perform 30 trials of a 2 span unstructured task over the same time period. After 6 weeks of training, subjects will be reassessed using the baseline battery of tasks, and re-imaged with functional magnetic resonance imaging (fMRI) performing the same verbal chunking task protocol.
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Primary outcome measure(s)
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1. Scores on verbal working memory task
2. Cerebral blood flow in the prefrontal and parietal cortices as measured using fMRI
Measured at baseline and after 8 weeks (following the 6 week cognitive training intervention).
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Secondary outcome measure(s)
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Scores on:
1. Spatial working memory task
2. Sustained attention, reasoning and episodic memory tasks
3. Artificial grammar task
4. Instrumental activities of daily living (ADL) task
Measured at baseline and after 8 weeks (following the 6 week cognitive training intervention).
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Sources of funding
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Medical Research Council (MRC) (UK) (ref: G0901982/ ID 93849)
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Trial website
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Publications
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Contact name
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Dr
Jonathan
Huntley
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Address
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Institute of Psychiatry
De Crespigny Park
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City/town
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London
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Zip/Postcode
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SE5 8AZ
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Country
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United Kingdom
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Sponsor
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Institute of Psychiatry (UK)
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Address
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c/o Professor Robert Howard
Kings College London
De Crespigny Park
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City/town
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London
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Zip/Postcode
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SE5 8AF
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Country
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United Kingdom
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Sponsor website:
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http://www.iop.kcl.ac.uk/
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Date applied
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10/12/2010
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Last edited
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07/02/2011
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Date ISRCTN assigned
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07/02/2011
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