Impact of a Cognitive Intervention Enriched With Leisure Activities in Persons With Subjective Cognitive Decline

NCT03271190 | Active Not Recruiting DMC

• 1 other identifier: CRIUGM-004
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Subjective Cognitive Decline

Keywords

aging; memory complaint

Outcome Measures

Primary Outcomes (1)

• Changes in episodic memory (composite score)

  A composite score will be computed by averaging z-scores from the delayed recall of the Rey Auditory Verbal Learning Test (RAVLT) and the delayed recall of the face-name association task (an associative memory test adapted from Simona Brambati's task for the Consortium pour l'Identification precoce de la Maladie d'Alzheimer (CIMA-Q) study currently running in Quebec).

  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)

Secondary Outcomes (8)

• Changes in attention control (composite score)

  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)

• Changes in psychological health: Anxiety and depression (composite score)

  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)

• Changes in psychological health: Apathy

  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)

• Changes in psychological health: Quality of life (composite score)

  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)

• Changes in psychological health: Help-seeking behaviour

  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)

Other Outcomes (7)

• Transfer to everyday life (self-reported): Meta-memory rating

  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)

• Transfer to everyday life (self-reported): Attention and recent memory rating

  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)

• Transfer to everyday life (self-reported): Activities of daily living

  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)

Study Arms (2)

ENGAGE SPANISH/MUSIC

EXPERIMENTAL

Cognitive strategies to improve attention and memory skills and application in selected leisure activities (music or Spanish lessons, and videogames) over 4 months.

Behavioral: ENGAGE SPANISH/MUSIC

ENGAGE DISCOVERY

ACTIVE COMPARATOR

Educational program about brain and healthy aging complemented by learning of new information with videogames, documentaries and group discussions over 4 months.

Behavioral: ENGAGE DISCOVERY

Interventions

ENGAGE SPANISH/MUSIC BEHAVIORAL

Cognitive strategies to improve attention and memory skills (21 hours), leisure activities (music lessons or Spanish lessons) (27 hours), selected videogames to practice variable attention strategies (4 hours in class + about 10 hours at home). Total of 24 2-hour in class sessions over 4 months. The training will be delivered to small groups of 5 to 8 participants by a trained therapist for formal sessions and a professional music or Spanish teacher for leisure sessions.

ENGAGE SPANISH/MUSIC

ENGAGE DISCOVERY BEHAVIORAL

Educational content about brain and healthy aging (21 hours), leisure activities (watching documentaries followed by group discussion and debate) (27 hours), selected non-stimulating videogames (4 hours in class + about 10 hours at home). Total of 24 2-hour in class sessions over 4 months. The training will be delivered to small groups of 5 to 8 participants by the same trained therapist as in the ENGAGE arm.

ENGAGE DISCOVERY

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Serious comorbid condition that, in the opinion of the study investigator, is likely to result in death within a year.
• Major depression or anxiety.
• Schizophrenia or other major psychiatric disorder.
• Ongoing alcohol or drug abuse that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
• Subject does not have a study partner who can provide corroborative information.
• Individuals where English (Toronto) or French (Montreal) is not sufficiently proficient for clinical assessment and neuropsychological testing.
• Unable to undergo MRI scan due to medical contraindications or inability to tolerate the procedure.
• Plans on moving outside the province within the next 2 years.
• Musicianship: more than 5 years of formal music training in total life or more than 10 years of choir experience.
• Fluency in Spanish: has learned Spanish after secondary school for more than 5 years, speaks Spanish at home, has ever lived in a Hispanic country.

Sponsors & Collaborators

• Rotman Research Institute at Baycrest: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal: lead

Study Sites (2)

Rotman Research Institute, Baycrest

Toronto, Ontario, M6A 2E1, Canada

Location

CRIUGM

Montreal, Quebec, h3w 1w4, Canada

Location

Related Publications (1)

• Belleville S, Moussard A, Ansaldo AI, Belchior P, Bherer L, Bier N, Bohbot VD, Bruneau MA, Cuddy LL, Gilbert B, Jokel R, Mahalingam K, McGilton K, Murphy KJ, Naglie G, Rochon E, Troyer AK, Anderson ND. Rationale and protocol of the ENGAGE study: a double-blind randomized controlled preference trial using a comprehensive cohort design to measure the effect of a cognitive and leisure-based intervention in older adults with a memory complaint. Trials. 2019 May 22;20(1):282. doi: 10.1186/s13063-019-3250-6.

  PMID: 31118095 DERIVED

Study Officials

• Sylvie Belleville, PhD

  Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D, Full professor, University of Montreal, and Scientific Director, Institut Universitaire de Geriatrie de Montreal (IUGM)

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: September 5, 2017
• Study Start: September 15, 2017
• Primary Completion: June 30, 2022
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)