Longitudinal study on cognitive health and Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate factors and markers associated with cognitive performance in individuals with varying levels of brain amyloid burden, using PET imaging and CSF measurements over a period of up to 12 years. Participants aged over 65 will undergo assessments using plasma assays to measure amyloid and tau levels, which are linked to Alzheimer's disease. The study will track cognitive changes and the relationship between these biomarkers and cognitive decline, providing insights into the disease's progression.

Why it matters

Who can join: the full rules

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.

Where it's running

• Imperial College London
  London, United Kingdom Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.