Exploratory Evaluation of [11C]MPC6827

NCT04575727 | Completed Early Phase 1 FDA Drug

• 1 other identifier: AAAS4926
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurodegenerative Diseases; Alzheimer Disease; Amyotrophic Lateral Sclerosis

Keywords

[11C]MPC6827

Outcome Measures

Primary Outcomes (2)

• Biodistribution of [11C]MPC6827

  Total body residence time and visual examination of whole body PET/CT images will be used to determine biodistribution of \[11C\]MPC6827.

  up to 48 hours from injection

• Estimation of clearance of [11C]MPC6827

  Serial venous blood draws (about 5 ml per sample) will be taken for estimation of clearance of \[11C\]MPC6827.

  Up to 48 hours from injection

Study Arms (2)

Health Volunteers

EXPERIMENTAL

In the first stage, five healthy human subjects will receive a microdose (10 µg) of \[11C\]MPC6827, immediately followed by whole body PET/CT to determine dosimetry and perform an initial safety evaluation of the radiotracer. A dose of 20 mCi \[11C\]MPC6827 will be administered and serial whole body PET scans will be acquired up to 2 hours post injection.

Drug: [11C]MPC6827

Patients with Neurodegenerative Disorders

EXPERIMENTAL

Up to 30 patients with neurodegenerative disorders will receive a microdose (10 µg) of \[11C\]MPC6827 and be imaged dynamically for up to 90 minutes using PET/CT for research purposes.

Drug: [11C]MPC6827

Interventions

[11C]MPC6827 DRUG

Subjects will receive a microdose ( 10 µg) of \[11C\]MPC6827 (dose of 20 mCi)

Also known as: [11C]MPC

Health Volunteers; Patients with Neurodegenerative Disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All volunteers must be 18 years of age or older, able to read, understand and voluntarily sign and informed consent document.
• Volunteers must have no current medical history of brain disease
• Negative pregnancy test if female of childbearing potential.
• 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.
• All volunteers must be 18 years of age or older, able to read, understand and voluntarily sign and informed consent document.
• Subjects must have a diagnosis of Alzheimer's Disease or ALS for which they are under a physician's care.
• Subjects must have a negative pregnancy test if female of childbearing potential
• 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.

You may not qualify if:

• 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.
• Concomitant medication use that, in the judgement of the investigator, would make the participant inappropriate for enrolment.
• Severe concurrent disease, infection, or medical co-morbidity that, in the judgement of the investigator, would make the participant inappropriate for enrolment.
• Participants who are receiving other investigational radiation drugs.
• Women who are pregnant or breast feeding.
• Subjects who are unable to tolerate PET/CT imaging

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Cuimc / Nyp

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Neurodegenerative Diseases; Alzheimer Disease; Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Nervous System Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders; Spinal Cord Diseases; Motor Neuron Disease; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Akiva Mintz, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: January 8, 2021
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)