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SYNERGIC-2 Trial (SYNchronizing, Exercises and Remedies to GaIn Cognition@Home)

A legfontosabb adatok

Ki végzi
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Hol
Kanada8 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toboroz
Résztvevők
250 fő, tervezett
Kezdés
2023. jún. 5.
Várható befejezés
2028. dec. 30.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • PMI@Home
  • Brain Health Pro
A regiszteradat frissítve
2026. szeptember 21.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults aged 60-85 with mild cognitive impairment (MCI) and at least 1 dementia risk factor. The program is done at home, online.

Életkor
60 to 85 years
Nem
All sexes
A betegség stádiuma
Mild cognitive impairment: memory complaints, low scores on memory and thinking tests, daily activities still managed, no dementia. Examples: MoCA score between 16 and 25, RAVLT delayed recall ≤6, or CDR =0.5.
Biomarker vagy leletérték
At least 1 risk factor: less than 150 minutes of exercise per week, poor diet (MDA-14 score ≤7), sleep problems (ISI score >7), or heart and blood vessel risk (CAIDE score ≥6, diabetes, BMI≥30, high blood pressure, or smoking).

A részvétel fő kizáró okai

  • A diagnosis of dementia.
  • Severe illness that stops taking part, such as major depression, schizophrenia, severe anxiety, parkinsonism, stroke with movement problems, uncontrolled heart failure or COPD, or advanced active cancer.
  • Surgery in the last 2 months, or planned surgery in the next 12 months that could affect taking part.
  • Regular use of benzodiazepine or neuroleptic drugs, or drug or alcohol abuse in the past 12 months or now.
  • A severe heart attack in the 6 months before joining, or plans to join other interventional trials.

A regiszter feltételei, szó szerint

Mind a 16 feltétel megnézéseKevesebb

Ki vehet részt

  • Ages 60-85 years
  • Having mild cognitive impairment (MCI) defined as meeting all of the following:; Presence of subjective memory complaints from the participant and/or informant; Objective impairment on cognitive tests independent of outcome measures.†; Preserved activities of daily living assessed (>14/23 in Lawton-Brody IADL score). For the study, impairment of daily living will be assessed based on cognitive abilities, not physical abilities; Absence of clinical dementia per DSM-IV criteria †Objective cognitive impairment is operationalized as: Montreal Cognitive Assessment (MoCA) total score between 16 and 25 (inclusive), and/or RAVLT delayed recall ≤6, and /or Clinical Dementia Rating Scale (CDR) =0.5
  • Have at least 1 dementia risk factors targeted by our intervention as follows: low physical activity (less than 150 minutes of moderate-to-vigorous-intensity physical activity per week, as per GAQ), poor diet (14-item Mediterranean Diet Assessment (MDA-14) score ≤7), insomnia or subthreshold insomnia ( Insomnia Severity Index (ISI) score >7), and vascular-metabolic risk (Cardiovascular Risk Factors Aging and Incidence of Dementia (CAIDE) score ≥6 and/or diabetes (type I or II) and/or obesity (BMI≥30) and/or diagnosis of high blood pressure (hypertension) and/or smoking)
  • Have access to a home computer/laptop/tablet with home internet (have regular access to email) and ability to use technology (able to send and receive emails and join video conferences)
  • Self-reported levels of proficiency in English for speaking and understanding spoken and written language
  • Have normal/corrected to normal vision in at least one eye to identify stimuli on computer/tablet screen
  • Have normal to corrected hearing ability, in order for the participant to engage in digital/virtual communication. Research personnel will determine and assess the hearing ability as per participant's performance
  • Able to comply with virtual visits, treatment plan, and trial-related activities
  • Ability to participate in the study's exercise training as determined by the Get Active Questionnaire (GAQ)

Ki nem vehet részt

  • Having had surgery within the last 2 months or having an upcoming planned surgery in the next 12 months that could interfere with the participant's vision, hearing, mobility, or any other abilities to participate in the study
  • Regular use of Benzodiazepine or neuroleptic drugs that may interfere with the participants ability to participate in the assessments and interventions
  • Having had a transmural myocardial infarction (severe heart attack) within six months prior to enrollment in the clinical trial that according to the study physician may preclude physical activity performance
  • Having a diagnosis of dementia (based on DSM-IV criteria)
  • Underlying severe disease that precludes engagement with interventions, including presence of psychiatric diagnoses (i.e., major depression (Geriatric Depression Scale (GDS-30) >19), schizophrenia, severe anxiety, neurological disorder with severe motor deficits, such as current parkinsonism or any neurological disorder with residual severe motor deficits (i.e., stroke with motor deficit), or presence of unstable (non-controlled e.g., symptoms that suggest instability or no treatment for their condition) chronic disease such as congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) that may preclude the participant from engaging properly with the trial interventions, or advanced-stage active cancer that at the study physician's discretion will prevent them from participating
  • Recent (in the past 12 months) and/or current substance or alcohol abuse
  • Intention to enroll in other interventional clinical trials during same time

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 60 és 85 év között vagy?

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

In Canada, 1,700,000 adults are at risk of dementia, half of them with MCI,representing one of the largest groups at risk for an incurable disease. Epidemiological evidence suggests up to 40% of dementia cases might be preventable by targeting modifiable lifestyle and cardiovascular factors. Given that current treatments cannot modify the disease, prevention is critical. SYNERGIC-2 offers a "personalized multidomain intervention" that combines physical and cognitive training, sleep, diet, and vascular-metabolic interventions in individuals with MCI to synergistically enhance their overall brain health including cognition and contributes to maintaining their independence. Importantly, interventions will be provided at home using an existing virtual platform reducing delivery complexity and expanding the accessibility to a wider population, thus decreasing potential inequities. Improving older adults' brain health and achieving even a modest two-year dementia incidence delay will have a projected saving of $218 Billion in Canada's healthcare system over 30 years.

A vizsgálat 2 csoportja

  • SYNERGIC 2Már használt kezelés, összehasonlításként

    Personalized multidomain coached 1-to-1 interventions at home (PMI@Home) including: 1. Physical Exercise 2. Cognitive Training 3. Diet 4. Sleep 5. Vascular Risk Factors Control

    Kezelés: PMI@Home

  • Brain Health PRO (BHPro)Placebo, összehasonlításként

    Brain Health PRO (BHPROBHPRO) is an independent, educational program with content also related to: 1. Physical Exercise 2. Cognitive Training 3. Diet 4. Sleep 5. Vascular Risk Factors 6. Social engagement

    Kezelés: Brain Health Pro

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Home-based Personalized Multidomain RCT From the Canadian Therapeutic Platform for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP)
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
Illeszkedési kérdések
Forrás: NCT05375513: ki vehet részt
A regiszteradat frissítve
2026. szeptember 21.