Mild Cognitive ImpairmentPhase 1FarbMCI2012NCT01641328
Cognitive Activation Therapy for MCI: A Randomized Control Study
A Phase 1 study testing Cogntive Activation Training in people with Mild Cognitive Impairment, run by Rotman Research Institute at Baycrest at 1 site in Canada.
Trial summary
Mild cognitive impairment (MCI) describes an initial phase of cognitive decline, usually among older adults, in which a person notices a decline in attention or memory, and performs worse than normal on cognitive tests of such. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Cogntive Activation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Jul 2013
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjective complaint about decline in memory or attention
- > 1 deviation below age-norm performance on memory or attention tasks
- Independence in daily living
- English speaking
Who cannot join
- Neurological disorders (including aphasias) or reversible causes of dementia (e.g., hypothyroidism or B12 deficiency)
- Montreal Cognitive Assessment (MOCA) score < 24
- Clinical mood disorder such as depression or anxiety
- Other serious medical conditions that preclude participation in the program
Trial locations and contacts
1 site in 1 country.
Canada1 site
Baycrest
Toronto, Ontario, M6A2E1
Norman AS Farb, PhD, 416-785-2500 ext. 2737, nfarb@research.baycrest.org
Norman AS Farb, PhD
About this study
Official title: Phase 1 Study of Cognitive Activation Behavioral Therapy for MCI: A Randomized Waitlist-Control and Delayed Active-Control Study
Mild cognitive impairment (MCI) describes an initial phase of cognitive decline, usually among older adults, in which a person notices a decline in attention or memory, and performs worse than normal on cognitive tests of such. People with MCI are more likely to develop Alzheimer's disease or related dementia than others their same age, and so MCI is thought of as an early warning sign of progressive cognitive decline.
While some forms of MCI may be brought about by purely genetic causes, other cases may be due to a withdrawal of cognitive engagement with the world. In these cases, a rigorous program of cognitive training may be beneficial, halting or reversing symptom progression.
Read more
The current study will evaluate a multifaceted cognitive activation program on older adults with MCI. This group program is intensive, running for 10 weeks, 3 times per week, for a total of 100 hours of training. Training consists of meditation exercises for broad attention activation, Tai Chi exercises to integrate cognition with body awareness, and cognitive training through computerized attention, memory, and problem solving exercise.
Subjective impressions and objective measures of cognitive ability will be measured before and after the intervention. The investigators will also examine effects on mood and levels of daily function. Results will be compared to a waitlisted control group. The control group will subsequently be entered into a home-based version of the program for 10 weeks, with assessment before and after training, to look at the importance of the group meeting dynamic in promoting cognitive change.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Cogntive Activation Training, Waitlist Control / Home-based training
- Keywords
- Mild Cognitive Impairment, MCI, Meditation, Mindfulness, Cognitive Activation, Cognitive Training, Tai Chi
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogntive Activation TrainingBehavioural
Also called Computer-based cognitive training is provided by Lumosity
Mindfulness-based stress reduction - 30 minutes / class x 3 classes / week; optional home practice Tai Chi - 30 minutes / class x 3 classes / week; optional home practice Computer-based cognitive training - 20 minutes / class x 3 classes / week; optional home practice
Waitlist Control / Home-based trainingBehavioural
Also called Computer-based cognitive training is provided by Lumosity, Biofeedback relaxation training is provided by HeartMath
Computer-based cognitive training - 20 minutes / day Daily walking - 20 minutes / day Biofeedback relaxation Training - 20 minutes / day
| Study group | Role | What they receive |
|---|---|---|
| Waitlist Control / Home-based training | Active comparator | This group will serve as a waitlist control group while the active group is performing training. Following assessment at the end of the active group period, this group will begin home-based training and will be assessed at the end of that 10 week period. Receives: Behavioral: Waitlist Control / Home-based training |
| Cognitive Activation Group | Experimental | This group will attend the 3/week group intervention meetings over 10 weeks. Receives: Behavioral: Cogntive Activation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Processing Speed
Processing speed on computerized cognitive task.
Measured: Before and After Intervention
Memory
Tests of immediate recall and delayed recall, recognition, and familiarity.
Measured: Before and After Intervention
Executive Function
Tests of inhibition, task switching, and problem solving.
Measured: Before and After Intervention
Attention / Working Memory
Working memory measures such as digit span, selection of targets among distractors, etc.
Measured: Before and after intervention
Secondary outcomes (2)
Mood and Well-being
Tests of dysphoric affect and subjective quality of life
Measured: Before and after intervention
Daily Function
Tests of instrumental activities of daily living
Measured: Before and after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rotman Research Institute at Baycrest
- Sponsor type
- University, hospital or other
- Collaborators
- Roy Hintsa
- Responsible party
- Principal investigator, Norman Farb, Rotman Research Institute at Baycrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641328
- Sponsor's protocol ID
- RRI_Farb_001
- Acronym
- FarbMCI2012
- Status last verified
- Jul 2012
- First submitted
- 12 Jul 2012
- Last updated
- 16 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Cognitive Activation Behavioral Therapy for MCI: A Randomized Waitlist-Control and Delayed Active-Control Study
- ClinicalTrials.gov ID
- NCT01641328
- Acronym / sponsor ID
- FarbMCI2012 / RRI_Farb_001
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, MCI, Meditation, Mindfulness, Cognitive Activation, Cognitive Training, Tai Chi
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rotman Research Institute at BaycrestUniversity, hospital or other
- Collaborators
- Roy Hintsa
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 16 Jul 2012 (estimated)
- 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.
Mild cognitive impairment (MCI) describes an initial phase of cognitive decline, usually among older adults, in which a person notices a decline in attention or memory, and performs worse than normal on cognitive tests of such. People with MCI are more likely to develop Alzheimer's disease or related dementia than others their same age, and so MCI is thought of as an early warning sign of progressive cognitive decline.
While some forms of MCI may be brought about by purely genetic causes, other cases may be due to a withdrawal of cognitive engagement with the world. In these cases, a rigorous program of cognitive training may be beneficial, halting or reversing symptom progression.
The current study will evaluate a multifaceted cognitive activation program on older adults with MCI. This group program is intensive, running for 10 weeks, 3 times per week, for a total of 100 hours of training. Training consists of meditation exercises for broad attention activation, Tai Chi exercises to integrate cognition with body awareness, and cognitive training through computerized attention, memory, and problem solving exercise.
Subjective impressions and objective measures of cognitive ability will be measured before and after the intervention. The investigators will also examine effects on mood and levels of daily function. Results will be compared to a waitlisted control group. The control group will subsequently be entered into a home-based version of the program for 10 weeks, with assessment before and after training, to look at the importance of the group meeting dynamic in promoting cognitive change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist Control / Home-based training | Active comparator | Behavioral: Waitlist Control / Home-based trainingThis group will serve as a waitlist control group while the active group is performing training. Following assessment at the end of the active group period, this group will begin home-based training and will be assessed at the end of that 10 week period. |
| Cognitive Activation Group | Experimental | Behavioral: Cogntive Activation TrainingThis group will attend the 3/week group intervention meetings over 10 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjective complaint about decline in memory or attention
- > 1 deviation below age-norm performance on memory or attention tasks
- Independence in daily living
- English speaking
Key exclusion criteria (4 listed)
- Neurological disorders (including aphasias) or reversible causes of dementia (e.g., hypothyroidism or B12 deficiency)
- Montreal Cognitive Assessment (MOCA) score < 24
- Clinical mood disorder such as depression or anxiety
- Other serious medical conditions that preclude participation in the program
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 |
|---|---|---|
| Cogntive Activation TrainingAlso: Computer-based cognitive training is provided by LumosityMindfulness-based stress reduction - 30 minutes / class x 3 classes / week; optional home practice Tai Chi - 30 minutes / class x 3 classes / week; optional home practice Computer-based cognitive training - 20 minutes / class x 3 classes / week; optional home practice | Behavioural | Cognitive Activation Group |
| Waitlist Control / Home-based trainingAlso: Computer-based cognitive training is provided by Lumosity, Biofeedback relaxation training is provided by HeartMathComputer-based cognitive training - 20 minutes / day Daily walking - 20 minutes / day Biofeedback relaxation Training - 20 minutes / day | Behavioural | Waitlist Control / Home-based training |
Primary outcome
Processing Speed
Time frame: Before and After Intervention
Processing speed on computerized cognitive task.
Memory
Time frame: Before and After Intervention
Tests of immediate recall and delayed recall, recognition, and familiarity.
Executive Function
Time frame: Before and After Intervention
Tests of inhibition, task switching, and problem solving.
Attention / Working Memory
Time frame: Before and after intervention
Working memory measures such as digit span, selection of targets among distractors, etc.
2 secondary outcomes
Mood and Well-being
Time frame: Before and after intervention
Daily Function
Time frame: Before and after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
- Related info about Baycrest and the Rotman Research InstituteLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cogntive Activation Training in people with Mild Cognitive Impairment, run by Rotman Research Institute at Baycrest at 1 site in Canada.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Jul 2012. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Processing Speed (time frame: Before and After Intervention). The study lists 4 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 16 Jul 2012.