Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Cognition and Flow Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03656107
Recruitment Status : Recruiting
First Posted : September 4, 2018
Last Update Posted : October 15, 2019
Sponsor:
Collaborators:
The Dunhill Medical Trust
University Hospitals, Leicester
Leicestershire Partnership Trust
University of Nottingham
Lumosity
Information provided by (Responsible Party):
University of Leicester

Brief Summary:

About the research

There are currently 850,000 people living with dementia in the UK. 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

  1. To find out how acceptable and manageable this BT program is for people with dementia to undertake larger studies of BT in the future.
  2. To look for any benefits for people with dementia, such as, improvements in quality of life, ability to carry out everyday tasks, mood, and brain blood flow.

How will the research be carried out?

  • 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, GP 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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Mild Cognitive Impairment Aging Cognitive Impairment Behavioral: Cognitive Training Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Brain Training on Brain Blood Flow: The Cognition and Flow Study
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive training
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
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.
Other Name: Brain training

No Intervention: Waiting-list control
Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.



Primary Outcome Measures :
  1. Percentage of participants successfully recruited [ Time Frame: 17 months ]
    Feasibility

  2. 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 [ Time Frame: 17 months ]
    Feasibility

  3. Percentage of participants with full bilateral data for CBFv [ Time Frame: 17 months ]
    Feasibility

  4. Percentage of control participants willing to be randomised to waiting list control [ Time Frame: 17 months ]
    Feasibility


Secondary Outcome Measures :
  1. Change in cognition score as detected by the Addenbrooke's cognitive examination (ACE-III) [ Time Frame: 17 months ]
    cognitive function. Maximum score 100, minimum score 0. Sub scale scores: attention (0-18), language (0-26), fluency (0-14), visuospatial (0-16), memory (0-26). Higher score = better cognition.

  2. Change in functional status - Lawton Instrumental Activities of Daily Living (IADL) [ Time Frame: 17 months ]
    Functional status (maximum score =8, minimum score =0). Higher score is equivalent to better function.

  3. Change in mood - Geriatric Depression Scale (GDS-15) [ Time Frame: 17 months ]
    Mood, maximum score 15, minimum score 0. Severe depression = 10-15, mild depression = 5-9, no depression = 0-4.

  4. Change in quality of life measure - Dementia Quality of Life Measure (DEMQOL) [ Time Frame: 17 months ]
    Quality of life, minimum score 28, maximum score 112. higher score = better quality of life.

  5. Percentage increase in cerebral blood flow velocity (CBFv) from baseline [ Time Frame: 17 months ]
    Neurovascular function as measured by task activation, TCD protocol


Other Outcome Measures:
  1. Semi-structured interview or focus group constructed around the health belief model to identify the barriers to CT in patients with dementia. [ Time Frame: 17 months ]
    What are the barriers to CT in patients with dementia?

  2. Semi-structured interview or focus group constructed around the health belief model to identify the facilitators to CT in dementia. [ Time Frame: 17 months ]
    What are the facilitators (benefits) to brain training in patients with dementia?

  3. Semi-structured interview or focus group constructed around the health belief model to identify how CT programs can be adapted further to support the participation of patients with dementia. [ Time Frame: 17 months ]
    How can CT programs can be adapted further to support the participation of patients with dementia?

  4. Are there any additional benefits to CT programs not measured by traditional methods as perceived by the patients and their carers? [ Time Frame: 17 months ]
    Semi-structured interview or focus group constructed around the health belief model.

  5. Semi-structured interview or focus group constructed around the health belief model, to identify the lived experience of the patient and their carer and the impact CT has on them and their life. [ Time Frame: 17 months ]
    To explore the lived experience of the patient and their carer and the impact CT has on them and their life.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

One of:

  1. Healthy controls will be free of any medical co-morbidity or medication that could adversely affect cognition. Volunteers with well-controlled co-morbidities (i.e. hypertension, diabetes, will be considered for inclusion)
  2. MCI as defined by NIA/AA 2011 and Petersen criteria
  3. AzD as defined by the NIA/AA 2011 criteria

    And:

  4. 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).
  5. Willing to participate
  6. Capacity to consent to the study/personal consultee
  7. Patients on and off anti-dementia medications will be included (acetylcholinesterase inhibitors, glutamate receptor antagonists)
  8. Good understanding of written and spoken English
  9. Age >50 years
  10. Access to the internet and a computer/laptop or tablet device.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656107


Locations
Layout table for location information
United Kingdom
University Hospitals of Leicester NHS Trust Recruiting
Leicester, Leicestershire, United Kingdom, LE1 5WW
Contact: Lucy Beishon, MBChB    01162523134    lb330@le.ac.uk   
Contact: Victoria Haunton, BM MD    01162523134    vjh12@le.ac.uk   
Principal Investigator: Thompson G Robinson, MD         
Leicestershire Partnership Trust Recruiting
Leicester, Leicestershire, United Kingdom
Contact: Elizabeta Mukaetova-Ladinska    01163736405    eml12@le.ac.uk   
Contact: Lucy Beishon, MBChB    01162523134    lb330@le.ac.uk   
Principal Investigator: Thompson G Robinson, MD         
Sponsors and Collaborators
University of Leicester
The Dunhill Medical Trust
University Hospitals, Leicester
Leicestershire Partnership Trust
University of Nottingham
Lumosity
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT03656107    
Other Study ID Numbers: 0677
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders