Trial Outcomes & Findings for The Cognition and Flow Study (NCT NCT03656107)

NCT ID: NCT03656107

Last Updated: 2022-05-27

Results Overview

Feasibility

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: 15 months
• Results posted on: 2022-05-27

Participant Flow

Participants were recruited from memory services at the Leicestershire Partnership Trust, Join Dementia Research, and relatives and friends of those enrolled in the study. In addition, healthy volunteers were recruited from ongoing research studies at the University Hospitals of Leicester National Health Service Trust. Recruitment was from January 2019 to April 2020.

Participants were excluded if they did not have a temporal window for Transcranial Doppler Ultrasonography insonation. The trial was completed early due to Covid-19 and so the total number recruited (56) is less than the original planned (60).

Participant milestones

Measure	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. 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.	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.
Overall Study STARTED	28	28
Overall Study COMPLETED	25	27
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Cognition and Flow Study

Baseline characteristics by cohort

Measure	Cognitive Training n=28 Participants 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. 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.	Waiting-list Control n=28 Participants Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.	Total n=56 Participants Total of all reporting groups
Age, Continuous	67.96 years STANDARD_DEVIATION 9.10 • n=5 Participants	68.86 years STANDARD_DEVIATION 8.61 • n=7 Participants	68.41 years STANDARD_DEVIATION 8.79 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United Kingdom	28 participants n=5 Participants	28 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 months

Feasibility

Outcome measures

Measure	Cognitive Training n=28 Participants 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. 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.	Waiting-list Control n=28 Participants Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.
Percentage of Participants Successfully Recruited	28 Participants	28 Participants

PRIMARY outcome

Timeframe: 17 months

Feasibility

Outcome measures

Measure	Cognitive Training n=28 Participants 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. 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.	Waiting-list Control n=28 Participants Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.
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	22 Participants	25 Participants

PRIMARY outcome

Timeframe: 17 months

Feasibility CBFv as measured using transcranial Doppler ultrsonography (TCD)

Outcome measures

Measure	Cognitive Training n=28 Participants 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. 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.	Waiting-list Control n=28 Participants Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.
Percentage of Participants With Full Bilateral Data for Cerebral Blood Flow Velocity (CBFv)	22 Participants	25 Participants

PRIMARY outcome

Timeframe: 17 months

Feasibility

Outcome measures

Measure	Cognitive Training n=28 Participants 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. 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.	Waiting-list Control n=28 Participants Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.
Percentage of Control Participants Willing to be Randomised to Waiting List Control	28 Participants	28 Participants

SECONDARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Measure	Cognitive Training n=25 Participants 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. 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.	Waiting-list Control n=27 Participants Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.
Change in Cognition Score as Detected by the Addenbrooke's Cognitive Examination (ACE-III) From Baseline to Follow-up at 12 Weeks	0.88 score on a scale Standard Deviation 3.59	-0.38 score on a scale Standard Deviation 3.91

SECONDARY outcome

Timeframe: 12 weeks

Functional status (maximum score =8, minimum score =0). Higher score is equivalent to better function.

Outcome measures

Measure	Cognitive Training n=25 Participants 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. 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.	Waiting-list Control n=27 Participants Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.
Change in Functional Status - Lawton Instrumental Activities of Daily Living (IADL) From Baseline to Follow-up at 12 Weeks	0.04 units on a scale Standard Deviation 0.84	0.04 units on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: 12 weeks

Mood, maximum score 15, minimum score 0. Severe depression = 10-15, mild depression = 5-9, no depression = 0-4.

Outcome measures

Measure	Cognitive Training n=25 Participants 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. 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.	Waiting-list Control n=27 Participants Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.
Change in Mood - Geriatric Depression Scale (GDS-15) From Baseline to Follow-up at 12 Weeks	-0.16 units on a scale Standard Deviation 1.37	0.41 units on a scale Standard Deviation 2.19

SECONDARY outcome

Timeframe: 12 weeks

Quality of life, minimum score 28, maximum score 112. higher score = better quality of life.

Outcome measures

Measure	Cognitive Training n=25 Participants 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. 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.	Waiting-list Control n=27 Participants Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.
Change in Quality of Life Measure - Dementia Quality of Life Measure (DEMQOL) From Baseline to Follow-up at 12 Weeks	2.12 units on a scale Standard Deviation 5.60	-1.74 units on a scale Standard Deviation 8.66

SECONDARY outcome

Timeframe: 12 weeks

Neurovascular function as measured by task activation, TCD protocol. Continuous CBFv was measured using TCD whilst participants underwent five cognitive tasks from the ACE-III. Task activation was measured as the percentage change in CBFv from 20 second prior to the task. T2 is the percentage change at 5-10 seconds after the task and T3 is the percentage change at 10-20 seconds after the task.

Outcome measures

Measure	Cognitive Training n=22 Participants 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. 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.	Waiting-list Control n=25 Participants Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.
Percentage Increase in Cerebral Blood Flow Velocity (CBFv) From Baseline to Follow-up at 12 Weeks T2	-1.71 percentage change of CBFv Standard Deviation 5.84	1.62 percentage change of CBFv Standard Deviation 5.17
Percentage Increase in Cerebral Blood Flow Velocity (CBFv) From Baseline to Follow-up at 12 Weeks T3	-1.45 percentage change of CBFv Standard Deviation 4.84	0.39 percentage change of CBFv Standard Deviation 5.18

Adverse Events

Cognitive Training

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Waiting-list Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cognitive Training n=28 participants at risk 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. 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.	Waiting-list Control n=28 participants at risk Control participants will be waiting listed to receive the brain training program at the end of the study. control participants will undergo usual care.
General disorders Drop-out	10.7% 3/28 • Number of events 3 • 15 months	0.00% 0/28 • 15 months

Additional Information

Dr Lucy Beishon

University of Leicester

Phone: 0116252

Email: lb330@le.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place