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 @ 1:16 PM
Ignite Modification Date:
2025-12-24 @ 1:16 PM
NCT ID:
NCT05669495
Eligibility Criteria:
Inclusion Criteria:
* The only inclusion criteria for this study is that participants must have consented and enrolled into a CTU affiliated study. There are no additional inclusion criteria. Individuals from CTU affiliated studies will be asked to confirm their enrollment in a CTU affiliated study as part of the informed consent process for this study.
For reference, inclusion criteria of CTU affiliated studies from which we will recruit may include, but are not limited to, the following list:
1. Ages 60-85
2. Sufficient proficiency in English or French
3. Technical ability to participate in remote assessments
4. Meets criteria for No Dementia and one of the following (according to CCNA Criteria):
1. Cognitively Unimpaired
2. Cognitively Unimpaired plus Subjective Cognitive Impairment
3. Mild Cognitive Impairment (MCI)
5. AND Classified as being at increased risk of dementia based on at least one of the following: a. First-degree family history of dementia b. Self-Reported or documented current and/or history at midlife (45-60 years) of the following risk factors: i. Hypertension ii. Hypercholesterolemia iii. Body Mass Index \> 30 kg/m2 iv. Physical Inactivity v. Insomnia vi. Vascular-metabolic risk
Exclusion Criteria:
1. Known nickel allergy
2. Known cardiac implantable device
3. Known arrhythmias
4. Otherwise unable to use the sensors; for example, finger amputations
For reference, exclusion criteria of CTU affiliated studies from which we will recruit may include, but are not limited to, the following list:
1. Participants who, in the opinion of the investigator, are not able to complete trial procedures remotely or adhere to the schedule of study assessments.
2. Individuals where English or French is not sufficiently proficient for remote clinical assessment.
3. Individuals who do not have the technical ability. Technical ability is defined as having computer and internet access; ability to send and receive emails; ability to participate in remote assessments.
4. Individuals who have a clinical diagnosis of Dementia
5. Clinical Dementia Rating (CDR; telephone/video-conference administration) Score of \>1 or having a diagnosis of dementia based on DSM-IV criteria
6. Total Score on the Montreal Cognitive Assessment (MoCA; video-conference administration) \<13
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT05669495
Study Brief:
Protocol Section:
NCT05669495