Functional anatomy and impact of cognitive training on chunking within working memory in early Alzheimer's disease

ISRCTN	ISRCTN43007027
DOI	https://doi.org/10.1186/ISRCTN43007027
Protocol serial number	Version 1 (13.7.10); G0901982
Sponsor	Institute of Psychiatry (UK)
Funder	Medical Research Council (MRC) (UK) (ref: G0901982/ ID 93849)

Submission date: 10/12/2010
Registration date: 07/02/2011
Last edited: 24/10/2016

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 Jonathan Huntley
Scientific

Institute of Psychiatry
De Crespigny Park
London
SE5 8AZ
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Functional anatomy and impact of cognitive training on chunking within working memory in early Alzheimer's disease: a randomised controlled trial
Study objectives	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
Ethics approval(s)	Cambridgeshire 1 Research Ethics Committee, 21/10/2010, ref: 10/H0304/68
Health condition(s) or problem(s) studied	Early Alzheimer's disease
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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).
Completion date	05/08/2014

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	30
Key inclusion criteria	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
Key exclusion criteria	1. Co-existent neurological or psychiatric disease 2. Substance misuse 3. Significant auditory or visual impairment
Date of first enrolment	20/12/2010
Date of final enrolment	05/08/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Psychiatry

London
SE5 8AZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/10/2016: Publication reference added.