Cognitive SymptomNCT04118985
Compensatory Training to Support Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease
A study testing Cognitive rehabilitation and health behavior change intervention and Self-implementation in people with Cognitive Symptom and Pre Senile Dementia, run by Mayo Clinic at 1 site in United States.
Trial summary
The Researchers are trying to better understand if behavioral interventions can help improve memory compensation and engagement in healthy lifestyle behaviors in those with memory concerns but normal mental status exam. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Symptom, Pre Senile Dementia, Alzheimer Disease
- What is being tested?
- Cognitive rehabilitation and health behavior change intervention and Self-implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2019to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50 or older
- A positive complaint or concern in response to two questions ('Do you feel like your memory or other aspects of thinking are becoming worse?' and 'Does this worry you?')
- Normal cognitive performance on the Montreal Cognitive Assessment (adjusted for age and education)
- Self-reported independent function in daily life as measure by the Lawson IADL scale (IADL=8)
- English speaking
- Approval letter from a physician (due to the exercise component)
Who cannot join
- Known neurological disorder with potential cognitive symptoms (a diagnosis of Parkinson's disease, epilepsy, a history of significant TBI, etc.)
- Uncontrolled moderate or severe depression (e.g., CES-D > 21).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compensatory Training to Support Everyday Function and Adherence to Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease
The Researchers are trying to better understand if behavioral interventions can help improve memory compensation and engagement in healthy lifestyle behaviors in those with memory concerns but normal mental status exam.
- Conditions
- Cognitive Symptom, Pre Senile Dementia, Alzheimer Disease
- Being tested
- Cognitive rehabilitation and health behavior change intervention, Self-implementation
- Keywords
- Subjective cognitive complaint
- Medical subject headings
- Neurobehavioral Manifestations, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive rehabilitation and health behavior change interventionBehavioural
Cognitive rehabilitation and health behavior change intervention in a group-based program intervention compared to self-implementation of techniques without these interventions
Self-implementationBehavioural
Self-implementation of cognitive rehabilitation and health behavior change recommendations
| Study group | Role | What they receive |
|---|---|---|
| Self-implementation | Active comparator | Individuals randomized to this group will be given all the materials about cognitive compensations techniques and brain health behavior guidelines and encouraged to implement those on their own. Receives: Behavioral: Self-implementation |
| Health-behavior intervention | Experimental | Individuals randomized to this group will attend 10 weekly classes designed to provide information about cognitive compensation techniques and brain health behaviors as well as interventional support to implement those recommendations with homework and follow-up classes. Receives: Behavioral: Cognitive rehabilitation and health behavior change intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Everyday Compensation Questionnaire
self-report and informant report if an informant is available of compensatory strategy use; range 0-148 with higher scores indicating more compensatory use
Measured: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Lifestyle Activities Questionnaire
self-report of cognitive activities, range 13-65 with higher scores indicating more activity
Measured: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
BrainHQ
Number of minutes on BrainHQ computer exercise program
Measured: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Physical Activities Questionnaire
self-report of physical activity; scores include number of days per week across 7 activity types and number of minutes in each activity when completed.
Measured: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Mindful Attention Awareness Scale
self-report of mindfulness, range of 11-66 with higher scores indicating more mindful daily experience
Measured: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Secondary outcomes (9)
Everyday Cognition
self-report of everyday functioning, range 39-156 with higher scores indicating more problems in daily functioning
Measured: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Quality of Life (in aging and cognitive health)
self-report of quality of life, range of 13-52 with higher scores indicating better quality of life
Measured: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Psychological well-being
self-report of psychological well-being/happiness; there is a total score plus subscales of autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, self-acceptance. Each subscale has 9 items for a total of 54 items. Total scores range from 54-324 with higher scores indicating higher psychological well being. Each subscale ranges from 9-54 with higher scores indicating greater well-being on that construct.
Measured: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Centers for Epidemiological Studies - Depression
self-report of symptoms of depression.Range 0-60 with higher scores indicating more depression
Measured: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Cognitive measure of memory
Hopkins Verbal Memory test. Staff administered standardized verbal memory task. Scores include total words recalled and total recalled after a delay with higher scores indicating greater recall
Measured: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
cognitive measure of executive functioning
Trailmaking test; Staff administered standardized measure of attention and executive functioning. Scores include time to complete the task (with higher scores being slower) and number of errors
Measured: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
cognitive measure of verbal fluency
Controlled Oral Word Association Test; Staff administered standardized measure of speed and verbal fluency. Score is number of items in one minute with higher scores indicating better functioning
Measured: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
cognitive measure of visual scanning speed
Symbol Digit Modalities Test; Staff administered standardize measure of speed and visual scanning. Scores indicate number of items completed in the time frame with higher scores indicating better functioning.
Measured: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
cognitive measure of response inhibition
Stroop Color Word Test; Staff administered standardized measure of speed and response inhibition. Scores indicate number of items completed in the time limit with higher scores indicating better functioning
Measured: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start10 Oct 2019
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive SymptomStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized to one of 1 arms: 1) provided recommendations and materials without coaching for implementation 2) provided recommendations and materials with 10 coaching classes
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dona E. Locke, Mayo Clinic
- Investigators
- Dona Locke, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118985
- Sponsor's protocol ID
- 19-006676
- Status last verified
- Nov 2020
- First submitted
- 8 Sep 2019
- Last updated
- 17 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is quite small and is meant a pilot data for preliminary feasibility and effect size estimating.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compensatory Training to Support Everyday Function and Adherence to Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04118985
- Acronym / sponsor ID
- 19-006676
- Conditions
- Cognitive Symptom, Pre Senile Dementia, Alzheimer Disease
- Keywords
- Subjective cognitive complaint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Researchers are trying to better understand if behavioral interventions can help improve memory compensation and engagement in healthy lifestyle behaviors in those with memory concerns but normal mental status exam.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized to one of 1 arms: 1) provided recommendations and materials without coaching for implementation 2) provided recommendations and materials with 10 coaching classes
| Arm | Type | Receives |
|---|---|---|
| Self-implementation | Active comparator | Behavioral: Self-implementationIndividuals randomized to this group will be given all the materials about cognitive compensations techniques and brain health behavior guidelines and encouraged to implement those on their own. |
| Health-behavior intervention | Experimental | Behavioral: Cognitive rehabilitation and health behavior change interventionIndividuals randomized to this group will attend 10 weekly classes designed to provide information about cognitive compensation techniques and brain health behaviors as well as interventional support to implement those recommendations with homework and follow-up classes. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 50 or older
- A positive complaint or concern in response to two questions ('Do you feel like your memory or other aspects of thinking are becoming worse?' and 'Does this worry you?')
- Normal cognitive performance on the Montreal Cognitive Assessment (adjusted for age and education)
- Self-reported independent function in daily life as measure by the Lawson IADL scale (IADL=8)
- English speaking
Key exclusion criteria (2 listed)
- Known neurological disorder with potential cognitive symptoms (a diagnosis of Parkinson's disease, epilepsy, a history of significant TBI, etc.)
- Uncontrolled moderate or severe depression (e.g., CES-D > 21).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive rehabilitation and health behavior change interventionCognitive rehabilitation and health behavior change intervention in a group-based program intervention compared to self-implementation of techniques without these interventions | Behavioural | Health-behavior intervention |
| Self-implementationSelf-implementation of cognitive rehabilitation and health behavior change recommendations | Behavioural | Self-implementation |
Primary outcome
Everyday Compensation Questionnaire
Time frame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
self-report and informant report if an informant is available of compensatory strategy use; range 0-148 with higher scores indicating more compensatory use
Lifestyle Activities Questionnaire
Time frame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
self-report of cognitive activities, range 13-65 with higher scores indicating more activity
BrainHQ
Time frame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Number of minutes on BrainHQ computer exercise program
Physical Activities Questionnaire
Time frame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
self-report of physical activity; scores include number of days per week across 7 activity types and number of minutes in each activity when completed.
Mindful Attention Awareness Scale
Time frame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
self-report of mindfulness, range of 11-66 with higher scores indicating more mindful daily experience
9 secondary outcomes
Everyday Cognition
Time frame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Quality of Life (in aging and cognitive health)
Time frame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Psychological well-being
Time frame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Centers for Epidemiological Studies - Depression
Time frame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Cognitive measure of memory
Time frame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
cognitive measure of executive functioning
Time frame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
cognitive measure of verbal fluency
Time frame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
cognitive measure of visual scanning speed
Time frame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
cognitive measure of response inhibition
Time frame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. The study is quite small and is meant a pilot data for preliminary feasibility and effect size estimating.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dona Locke, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive rehabilitation and health behavior change intervention and Self-implementation in people with Cognitive Symptom and Pre Senile Dementia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Everyday Compensation Questionnaire (time frame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.