Subjective Cognitive Decline Clinical Trial
Official title:
Impact of a Cognitive Intervention Enriched With Leisure Activities on Cognition, Daily Life Functioning and Brain Structure and Function in Persons With Subjective Cognitive Decline: The ENGAGE Program
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.
Status | Active, not recruiting |
Enrollment | 144 |
Est. completion date | March 31, 2024 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility | 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. - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | CRIUGM | Montreal | Quebec |
Canada | Rotman Research Institute, Baycrest | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal | Canadian Institutes of Health Research (CIHR), Rotman Research Institute at Baycrest |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Transfer to everyday life (self-reported): Meta-memory rating | Mean scores from the Meta-memory questionnaire (MMQ). | 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 | Transfer to everyday life (self-reported): Attention and recent memory rating | Mean scores from the Auto-administered Memory Questionnaire (AMQ, short version). | 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 | Transfer to everyday life (self-reported): Activities of daily living | A composite score will be computed that aggregates the average z-scores from the participant + informant versions of the Alzheimer's Disease Cooperative Study - Activities of Daily Living - Prevention Instrument (ADCS-ADL-PI). | 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 | Transfer to everyday life (self-reported): Cognitive activities | Mean scores from the Cognitive Activities questionnaire. | 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 | Transfer to everyday life (self-reported): Jessen's Questions | The number of participants that do not have a memory complaint. | 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 | Transfer to everyday life (performance-based): Instrumental Activities of Daily Living | Mean scores from the Direct Assessment of Functional Status - Revised (DAFS-R), an ecologically-valid task assessing everyday life situations. | 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 | Transfer to everyday life (performance-based): Memory Strategies | Mean scores from the Memory Toolbox Test, a questionnaire assessing the knowledge of memory strategies. | 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) | |
Primary | 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 | Changes in attention control (composite score) | A composite score will be computed by averaging the z-scores from the Number-letter task (switching cost), the complex (4-choice) reaction time from the Canadian Longitudinal Study on Aging (CLSA) Reaction Time Task, and an adapted Flanker task comprising a dual-task condition (congruency effect and dual task cost). | 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 | Changes in psychological health: Anxiety and depression (composite score) | A composite score will be computed by averaging the z-scores from the Geriatric Anxiety Inventory (GAI) + Geriatric Depression Scale (GDS). | 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 | Changes in psychological health: Apathy | A composite score will be computed that averaging the z-scores from the participant + informant versions of the Apathy Inventory Scale. | 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 | Changes in psychological health: Quality of life (composite score) | A composite score will be computed by averaging the z-scores from the 36-item Short Form Survey (SF-36), assessing activities and well-being, and the Quality of Life Alzheimer's Disease questionnaire (QoL-AD). | 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 | Changes in psychological health: Help-seeking behaviour | Mean scores from the medical care section from the Stanford Chronic Disease questionnaire, related to medical help-seeking behavior. | 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 | Changes in brain structure: Hippocampal Volume (for a subgroup of participants) | Participants will be scanned on a Siemens Total Imaging Matrix (TIM) Trio 3 T magnetic resonance imaging (MRI) system (Siemens Medical Solutions, Erlangen, Germany). Hippocampal volume (mm3) will be measured, as this is an early biomarker of AD and is found to be a sensitive marker of memory training. | 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 | Changes in brain structure: Cortical Thickness (for a subgroup of participants) | Participants will be scanned on a Siemens TIM Trio 3 T magnetic resonance imaging (MRI) system (Siemens Medical Solutions, Erlangen, Germany). Cortical thickness (mm) will be measured, as this is an early biomarker of AD and is found to be a sensitive marker of memory training. | 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 | Changes in brain function: Brain activation (for a subgroup of participants) | fMRI activity while participants are doing an associative memory task. Participants will be presented a sequence of 80 images (e.g., animals, vegetables, etc.). They appear within one of the four quadrants of the screen. People are asked to remember the images and their position among the 4 quadrants (either top-left, top right, bottom-left or bottom-right). Retrieval is done 10 minutes after the encoding, outside of the scanner. People are presented with the same 78 images in a new order and 39 new images, appearing one at a time in the center of the screen. They have to determine whether each image has been previously presented, and if 'Yes', where it was located. | PRE (within 12 weeks before intervention starts) + POST-1 (within 8 weeks after the end of intervention) |
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