Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT03035851
Eligibility Criteria:
Inclusion Criteria:
* inactive men and women aged 50-80 years (inclusive) with subjective cognitive symptoms but no dementia who have one or more vascular risk factors (see below) for ADRD;
* Inactivity will be assessed with a physical activity questionnaire and defined as engagement in \<3 sessions/week of 20 min or more of vigorous exercise;
* Subjective cognitive symptoms will be self-reported using the MAC-Q Memory Complaint Questionnaire, recently validated as a measure of subjective memory complaints in healthy elderly subjects, in patients with mild cognitive impairment, and in relation to AD biomarkers; participants with a score of ≥25 will be considered eligible.
* Vascular risk factors for ADRD including the following:
* history of hypertension;
* diabetes mellitus;
* obesity (body mass index (BMI) \<40 kg/m2)
* elevated cholesterol;
* currently smoking;
* past history of coronary artery disease without recent (\<5 years) symptoms.
Participants must provide a completed PAR-Q+ form (www.csep.ca), the standard method of obtaining physician approval for participation in an exercise program. For participants without a family doctor to provide this form, we will provide information on how to find a family doctor.
Exclusion Criteria:
* diagnosis of a developmental handicap;
* history of dementia (DSM-V criteria)\*\*;
* terminal illness (life expectancy \< 1 year)
* not fluent in verbal and written English;
* history of stroke;
* currently participating in another trial;
* comorbid medical or neurological illnesses (e.g., multiple sclerosis) that would confound cognitive assessments or make trial completion unlikely (in the site investigator's opinion);
* contraindication for the intervention;
* contraindication for an MRI exam.
* \*\*Existing or suspected dementia will be identified by medical history, cognitive impairment on the Telephone Interview for Cognitive Status (TICS-modified; score≤ 20), or impaired Instrumental Activities of Daily Living (IADL) - a response of needs assistance or dependent due to cognitive impairments on any item on the Lawton scale.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT03035851
Study Brief:
Protocol Section:
NCT03035851