AHEAD Plasma Extension Study

Overview

About this study

The purpose of this study is to collect longitudinal cognitive and functional assessments and blood-based biomarker data. Also, to evaluate, characterize, and compare the longitudinal cognitive and functional data between the three groups of participants, and to compare longitudinal change across race and ethnicity, sex, and APOE status.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusoin Criteria: 

  • Documentation of the participant’s informed consent to study procedures and for the use of PHI (HIPAA Authorization, if applicable):
    • NOTE: Informed consent processes and documentation must adhere to state laws/local requirements, including consent provided by the participant’s legally authorized representative (LAR), responsible next of kin, surrogate consent with assent, etc.
  • Previously consented to participate in A3-45 screening.
  • Has A3-45 screening plasma biomarker results required for determining eligibility to participate in the A3-45 trial.
  • If an amyloid PET scan was conducted in A3-45, the scan was determined to be below the 20 centiloid cutpoint required for eligibility into the treatment arms of the A3 or A45 trial.
  • As assessed by the site PI, participant is likely to be able to comply with the protocol, including completion of all required procedures for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy in English or Spanish sufficient for compliance with required testing procedures.

Exclusion Criteria:

  • Current treatment with an FDA approved medication for Alzheimer’s disease, including prior or current treatment with a prohibited medication as described in section 6.2.1.
  • Enrollment in another investigational study, or intake of investigational drug, within 30 days prior to screening, or five halflives of the investigational drug, whichever is longer, unless it can be documented that the participant was in the placebo treatment arm.
  • NOTE: Participants enrolled in other observational studies may be permitted with Medical Monitor review and approval.
  • Screen failed from A3-45 due to not meeting basic inclusion criterion (i.e., age requirement; current diagnosis of AD dementia).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/4/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jonathan Graff-Radford, M.D.

Open for enrollment

Contact information:

Alzheimer's Disease Research Center

(507) 284-1324

More information

Publications

Publications are currently not available
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CLS-20560119

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