Condition category
Nervous System Diseases
Date applied
10/12/2010
Date assigned
07/02/2011
Last edited
24/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jonathan Huntley

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1 (13.7.10); G0901982

Study information

Scientific title

Functional anatomy and impact of cognitive training on chunking within working memory in early Alzheimer's disease: a randomised controlled trial

Acronym

Study hypothesis

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

Cambridgeshire 1 Research Ethics Committee, 21/10/2010, ref: 10/H0304/68

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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).

Secondary outcome measures

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).

Overall trial start date

20/12/2010

Overall trial end date

05/08/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Co-existent neurological or psychiatric disease
2. Substance misuse
3. Significant auditory or visual impairment

Recruitment start date

20/12/2010

Recruitment end date

05/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry
London
SE5 8AZ
United Kingdom

Sponsor information

Organisation

Institute of Psychiatry (UK)

Sponsor details

c/o Professor Robert Howard
Kings College London
De Crespigny Park
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: G0901982/ ID 93849)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27758836

Publication citations

Additional files

Editorial Notes

24/10/2016: Publication reference added.