Exploratory Evaluation of [11C]MPC6827

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 0 study that will enable an assessment of biodistribution and estimation of absorbed dose in humans based on data collected from five healthy volunteers, which is typically the minimum number required by the FDA for first-in-human studies to assess dosimetry of a new tracer. The evaluation of the brain imaging of thirty additional subjects in the 2nd part of the study will lead to a descriptive assessment of the targeting and pharmacokinetics of MPC6827 in the brain and between normal and diseased brain.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Columbia University

Criteria

Inclusion Criteria (Healthy Volunteers)

1. All volunteers must be 18 years of age or older, able to read, understand and voluntarily sign and informed consent document.

2. Volunteers must have no current medical history of brain disease

3. Negative pregnancy test if female of childbearing potential.

4. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry for the duration of study participation.

Inclusion Criteria (Alzheimer's Disease or ALS)

1. All volunteers must be 18 years of age or older, able to read, understand and voluntarily sign and informed consent document.

2. Subjects must have a diagnosis of Alzheimer's Disease or ALS for which they are under a physician's care.

3. Subjects must have a negative pregnancy test if female of childbearing potential

4. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry for the duration of the study participation.

Exclusion Criteria:

1. Participants with evidence of brain disease other than ALS or Alzheimer's Disease at the time of enrolment up to agent administration are to be excluded from the study.

2. Concomitant medication use that, in the judgement of the investigator, would make the participant inappropriate for enrolment.

3. Severe concurrent disease, infection, or medical co-morbidity that, in the judgement of the investigator, would make the participant inappropriate for enrolment.

4. Participants who are receiving other investigational radiation drugs.

5. Women who are pregnant or breast feeding.

6. Subjects who are unable to tolerate PET/CT imaging