Impact of a Cognitive Intervention Enriched With Leisure Activities in Persons With Subjective Co… (NCT03271190) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Impact of a Cognitive Intervention Enriched With Leisure Activities in Persons With Subjective Cognitive Decline
Canada144 participantsStarted 2017-09-15
Plain-language summary
The team "Cognitive intervention, cognitive reserve and brain plasticity", Team 10, is part of the Canadian Consortium on Neurodegeneration in Aging (CCNA). The team's aim is to develop and test a multi-faceted intervention program meant to increase cognitive and brain reserve by providing cognitive stimulation through participation in cognitive training sessions and engaging leisure activities. This will be done with a partially randomized controlled double-blind preference trial with a comprehensive cohort design, in participants with subjective cognitive decline (SCD) recruited in Montreal and Toronto.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Possess sufficient visual and auditory acuity to undergo neuropsychological tests and to do the intervention.
* Commit for the whole intervention + 2 follow-up sessions 2 years from pre-test.
* Have an internet connection at home.
* Answer 'Yes' to both following questions: "Do you feel like your memory is becoming worse?" "Does this worry you?"
* Have a delayed recall score above the education-adjusted cut-offs (≥9 for 16+ years of education; ≥5 for 8-15 years of education; ≥3 for 0-7 years of education) at the Logical Memory test (Wechsler Memory Scale, maximum score 25).
* Have a Montreal Cognitive Assessment (MoCA) total score of 20 and above (≥20/30).
* Have a delayed recall score at the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List task above 4 (\>4).
* Have a global Clinical Dementia Rating score (CDR) equal to 0 or 0.5 (=0 to 0.5).
Exclusion Criteria:
* The presence of disease or injury of the central nervous system, such as: moderate to severe chronic static leukoencephalopathy (including previous traumatic injury), multiple sclerosis, a serious developmental handicap, subdural hematoma (past or current), subarachnoid haemorrhage (past or current), primary cerebral tumour or cerebral metastases, epilepsy (current), dementia or another neurodegenerative disease, and other rarer brain illnesses.
* Symptomatic stroke within the previous year.
* History of intracranial surgery.
* Major surgery within last 2 months.
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in episodic memory (composite score)
Timeframe: PRE (within 12 weeks before intervention starts) + POST-1 (within 8 weeks after the end of intervention) + POST-2 (2 years from PRE, +/- 3 months)
Trial details
NCT IDNCT03271190
SponsorCentre de Recherche de l'Institut Universitaire de Geriatrie de Montreal