Longitudinal study on cognitive health and Alzheimer's disease

Cognitive Health in Ageing Register: Investigational and Observational Trial Studies in Dementia Research (CHARIOT): Prospective Readiness Cohort (PRO) Longitudinal Study

This study is testing how changes in certain brain markers relate to memory and thinking skills in people over 65 to better understand Alzheimer's disease.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Imperial College London (other)
• Locations: 1 site (London)
• Trial ID: NCT06953167 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged over 65 who have undergone amyloid screening and are capable of providing informed consent.

Not a fit: Patients under 65 or those without the capacity to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance early detection and understanding of Alzheimer's disease, leading to improved patient management and treatment strategies.

How similar studies have performed: Other studies have shown promise in using biomarkers for Alzheimer's disease detection, indicating that this approach is supported by previous research.

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.

Where this trial is running

London

• Imperial College London — London, United Kingdom (RECRUITING)

Conditions: Alzheimer&#39, s Disease, Alzheimer's disease, Dementia, Longitudinal Study, Biomarkers, CHARIOT-PRO, Amyloid