The ADRC Consortium for Clarity in ADRD Research Through Imaging

SR

Shannon Risacher

Principal Investigator

Status: Enrolling By Invitation Ages: 55 Years - 100 Years Gender: All Genders Phase: N/A 1 Locations

Brief Description

This study seeks to identify the several possible causes of dementia that may be present in an individual, and that may be contributing to a person’s current or future cognitive symptoms. The study will run a panel of experimental and established biomarker tests for the several causes of dementia such as Alzheimer’s disease (AD), vascular disease, and Lewy Body Disease as well as less common or difficult to detect causes of dementia. Because these conditions are more likely as we age, and because they can begin prior to any symptoms, this study will enroll late middle-aged and older adults across the spectrum from cognitively normal, to mild symptoms, to dementia. 
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential research candidates will be selected from a pool of existing Alzheimer’s Disease Research Center (ADRC) participants. The recruitable pool will contain all ADRC participants with a NACC ID that meet the study criteria and will be contacted directly by the research team. 

Detailed Description

You will be asked to undergo a panel of imaging and blood tests. Because there are several tests to do, they will be scheduled over 2 to 4 different days.

  • The brain imaging tests include up to three types of positron emission tomography (PET) scans described below, and a magnetic resonance imaging (MRI) of your brain.
  • Some of these tests are well accepted standard procedures and some will include use of an experimental drug.
  • After your initial set of tests you will be asked to come back approximately two years later for follow-up tests.
  • There are no treatments in this study.
  • We expect that your taking part in this research study will last approximately 24 months.


Summary of procedures that may be done at each time point: 
 

  1. Eligibility Review
  2. MRI scan (if applicable)
  3. Vital signs (blood pressure, pulse, weight)
  4. Amyloid PET scan with one of the following tracers: PiB, florbetapir, florbetaben, or NAV4694 (the radiotracers NAV469, PiB, MK6240, and PI-2620 are investigational drugs)
  5. Tau PET scan with one of the following tracers: MK6240, PI-2620 or flortaucipir
  6. FDG PET scan to assess glucose metabolism

Eligibility of study

Inclusion 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 must meet at least one high priority characteristic

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.

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Visit allinforhealth.info to see if you're eligible and join the study.