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:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT06953167
Eligibility Criteria:
Inclusion Criteria:
* To be eligible, participants must meet all inclusion criteria for the study, as follows:
1. Male or Female, aged \>65years
2. Willing and having capacity (as assessed according to MCA 2005) to provide written informed consent and to participate in the study, OR (if lacking capacity) has a nominated consultee (as described in the MCA 2005 and Chapter 11 of the MCA Code of Practice 2007) who is able to advise that this is what the participant would have wished.
3. Have completed CPSS1 amyloid screening using either amyloid PET scanning or CSF Aβ42 measurement.
4. Be fluent in and able to read and write in English and have adequate hearing and visual acuity to complete the required psychometric tests.
5. Be willing and able to adhere to the study visits and assessments specified in this protocol, and the reasonable requests and expectations of the study staff.
6. Have a reliable informant - study partner (relative, partner, or friend) who is willing to provide their informed consent to participate, as a source of information. The study partner must be over 18 years old and should be fluent in and able to read and write in English. The informant must have sufficient contact with the participant and sufficient cognitive ability such that the Investigator feels that they can provide meaningful information about the participant's daily functioning. At a minimum, they must be in contact with the participant at least twice per month (in person, via telephone or other audio/visual communication). The study partner will be required in-person at the V1 visit. However, they can complete all subsequent visits remotely, or in-person if required.
Exclusion Criteria:
* To be eligible, participants must not meet any of the exclusion criteria for the study, as follows:
1. Participant has any disability that would prevent completion of study procedures or assessments (e.g. blindness or significant visual impairment, deafness or significant hearing impairment, speech impairment, or sensory or motor dysfunction), or has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the participant's well-being), or that could prevent, limit, or confound the results of protocol-specified assessments and cognitive testing.
2. Unable to comply with the study-specific requirements.
3. History of alcohol or drug dependence or abuse, as defined by the most current version of the DSM criteria within the last 3 years.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06953167
Study Brief:
Protocol Section:
NCT06953167