The Cognition and Flow Study

NCT03656107 | Terminated Results DMC

• 1 other identifier: 0677
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

About the research There are currently 850,000 people living with dementia in the United Kingdom. It is now understand that Alzheimer's disease (AzD) can result from damaged blood vessels in the brain. Brain blood flow can be measured using ultrasound, known as transcranial Doppler ultrasonography (or TCD). Brain training (BT) uses exercises or brain-teasers to try to make the brain work faster and more accurately. In recent years, BT has been used to try to improve memory, mood, learning, quality of life, and ability to carry out every-day activities in people with dementia. Aims

• Forty patients with AzD, or mild cognitive impairment (MCI), and twenty healthy older adults will be recruited from memory and geriatric clinics, Join Dementia Research, general practice surgeries and community groups.
• Participants will be randomly assigned to brain training or control. The control group will be offered the program at the end of the study.
• First visit: Participants will complete questionnaires on quality of life, mood, everyday abilities, memory and an assessment of brain blood flow
• Brain training program: Participants will complete 15-30 minute sessions, 3-5 times per week
• Follow-up: participants will repeat the questionnaires and assessment of brain blood flow
• Interviews and feedback: to discuss how participants felt the program went, and find out if there are any ways it could be improved.

Conditions

Dementia; Alzheimer Disease; Mild Cognitive Impairment; Aging; Cognitive Impairment

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants Successfully Recruited

  Feasibility

  15 months

• Percentage of Participants Able to Successfully Complete the Minimum (15 Mins, 3x Per Week, for 8 Weeks) and Maximum (30 Mins, 5x Per Week, for 12 Weeks) Criteria CT Program and Complete All Assessments

  Feasibility

  17 months

• Percentage of Participants With Full Bilateral Data for Cerebral Blood Flow Velocity (CBFv)

  Feasibility CBFv as measured using transcranial Doppler ultrsonography (TCD)

  17 months

• Percentage of Control Participants Willing to be Randomised to Waiting List Control

  Feasibility

  17 months

Secondary Outcomes (5)

• Change in Cognition Score as Detected by the Addenbrooke's Cognitive Examination (ACE-III) From Baseline to Follow-up at 12 Weeks

  12 weeks

• Change in Functional Status - Lawton Instrumental Activities of Daily Living (IADL) From Baseline to Follow-up at 12 Weeks

  12 weeks

• Change in Mood - Geriatric Depression Scale (GDS-15) From Baseline to Follow-up at 12 Weeks

  12 weeks

• Change in Quality of Life Measure - Dementia Quality of Life Measure (DEMQOL) From Baseline to Follow-up at 12 Weeks

  12 weeks

• Percentage Increase in Cerebral Blood Flow Velocity (CBFv) From Baseline to Follow-up at 12 Weeks

  12 weeks

Study Arms (2)

Cognitive training

EXPERIMENTAL

Participants selected to brain training will be given instructions on how to access and use the program at home for 15-30minutes, 3-5 times per week for 8-12 weeks.

Behavioral: Cognitive Training

Waiting-list control

NO INTERVENTION

Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.

Interventions

Cognitive Training BEHAVIORAL

Lumosity© is a commercially available software, developed by a group of neuropsychologists, which has been used across several studies of brain training and disciplines. The brain training software targets multiple brain areas, is based online, and is relatively easy to use and administer. It has been designed to adapt to the individual's memory performance to personalise the training program to their needs. Brain exercises will be selected with the support of Lumosity© to target the following brain areas; attention, memory, visuospatial, verbal fluency, and language.

Also known as: Brain training

Cognitive training

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One of:
• MCI as defined by National Institute on Aging and Alzheimer's Association (NIA-AA) 2011 and Petersen criteria
• AzD as defined by the NIA-AA 2011 criteria
• And:
• Deficits will be mild to moderate as defined by Montreal Cognitive Assessment (MoCA) score of 19-26 for MCI, and 9-18 for AzD (32-34).
• Willing to participate
• Capacity to consent to the study/personal consultee
• Patients on and off anti-dementia medications will be included (acetylcholinesterase inhibitors, glutamate receptor antagonists)
• Good understanding of written and spoken English
• Age \>50 years
• Access to the internet and a computer/laptop or tablet device.

You may not qualify if:

• Healthy controls with any medical co-morbidity or medication that could adversely affect cognition, or poorly controlled medical co-morbidities (i.e. hypertension, diabetes)
• Unwilling to take part
• Unable to consent/no personal consultee
• Major medical co-morbidity; severe heart failure (ejection fraction \<20%), carotid artery stenosis, severe respiratory disease, major stroke
• Pregnancy, planning pregnancy, or lactating
• Inadequate bilateral TCD windows
• Participants already enrolled into other interventional studies
• Insufficient understanding of written and spoken English
• Age \<50 years
• No access to the internet and a computer/laptop or tablet device

Sponsors & Collaborators

• University of Leicester: lead
• The Dunhill Medical Trust: collaborator
• University Hospitals, Leicester: collaborator
• Leicestershire Partnership NHS Trust: collaborator
• University of Nottingham: collaborator
• Lumosity: collaborator

Study Sites (2)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Leicestershire Partnership Trust

Leicester, Leicestershire, United Kingdom

Location

Related Publications (1)

• Beishon L, Evley R, Panerai RB, Subramaniam H, Mukaetova-Ladinska E, Robinson T, Haunton V. Effects of brain training on brain blood flow (The Cognition and Flow Study-CogFlowS): protocol for a feasibility randomised controlled trial of cognitive training in dementia. BMJ Open. 2019 May 22;9(5):e027817. doi: 10.1136/bmjopen-2018-027817.

  PMID: 31122994 DERIVED

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Cognition Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr Lucy Beishon
• Organization: University of Leicester

lb330@le.ac.uk

0116252

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 4, 2018
• Study Start: January 14, 2019
• Primary Completion: September 4, 2020
• Study Completion: September 4, 2020
• Last Updated: May 27, 2022
• Results First Posted: May 27, 2022

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)