Clinical Trials

Inclusion Criteria:

• Screening: Because the candidate participants are existing ADRC participants, a separate screening visit is not necessary. The recruitable pool will contain all ADRC participants with a NACC ID that meet the criteria listed below. Eligibility may be determined by querying local databases and other local resources and brief interview in person, by phone or remote videoconference. Candidate participants will be considered a screen failure if upon review of exclusion criteria, it is noted that their medical history or circumstances have changed. Candidate participants may be contacted and invited by phone, mailed letter, or by an in-person approach (such as their main ADRC visit or other center visit). An eligibility checklist is used to document that the potential participant meets criteria.
• An ADRC Clinical Core participant.
• Age at Enrollment: Participant age is 55 years or greater.
• Brain donor: Participant is enrolled in the site’s ADRC brain donation program (waived as needed for participants from under-represented populations—URP).
• Cognition: Cognitive stage is unimpaired, MCI or dementia (mild to moderate at the discretion of the site).
• If cognitively unimpaired, the participant meets any one of these high priority characteristics:
  • High priority characteristics for Cognitively Unimpaired
    • URP: Broadly defined; At higher risk for all cause dementia;
    • Less education: 12 or fewer years;
    • APOE4+; Higher risk for amyloid+ and earlier age of A+ onset;
    • First degree family history of dementia: From a neurodegenerative disease but need not be AD. This construct denotes non-specific genetic and environmental risk;
    • Vascular health factors: 1 or more of: HTN, cholesterol, diabetes, heart disease, current smoker, obesity, sleep apnea, etc;
    • Cognitive complaints: Subjective complaints are documented in UDS forms. Complaints may be from participant or informant;
    • Cognitive decline: Transitional decline based on judgment of the site team from collected history or from observed testing. Decline is not sufficiently severe to meet criteria for MCI;
    • Age > 75: Age is the greatest risk factor for all cause dementia;
    • Neurobehavioral features: REM-BD, MBI or other neurological features that in the judgment of the site is suggestive of an emerging ADRD.

Exclusion Criteria:

• Medications: There are no specific medications that are excluded. Persons currently undergoing FDA approved amyloid immunotherapy may enroll; persons who previously completed immunotherapy may enroll. Persons who enroll and subsequently begin FDA approved immunotherapy may continue.  
• Current experimental therapy: Persons receiving or scheduled to receive experimental amyloid or tau immunotherapy should not receive PI-2620. There are no clinical trial restrictions for the other radioligands in the study.
• Significant Medical or Neurologic Illness: Participants are excluded if, in the judgement of the site clinicians, they currently have severe and significant systemic, neurological or psychiatric illness or unstable medical condition which could impact ability to tolerate procedures or interpret the findings. Examples of excluded medical conditions include significant non-ADRD neurologic disease such as but not limited to Huntington’s disease, certain major cancer involving the CNS, current poorly controlled epilepsy, active Axis I DSM-V major psychotic disorder such as Schizophrenia.
• Pregnancy is excluded.
• MRI Contraindications: Participants with incompatible pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, or other contraindication are excluded from MRI exams unless screened and determined safe at the site. Participants with self reported claustrophobia, anxiety and/or discomfort to the confines of the MRI will be excluded. Contraindications for MRI do not necessarily apply to PET.

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

Eligibility last updated 1/29/24. Questions regarding updates should be directed to the study team contact.