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Exploratory Evaluation of [11C]MPC6827

Primary Purpose

Neurodegenerative Diseases, Alzheimer Disease, Amyotrophic Lateral Sclerosis

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

[11C]MPC6827

About this trial

This is an interventional basic science trial for Neurodegenerative Diseases focused on measuring [11C]MPC6827

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (Healthy Volunteers)

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.

Inclusion Criteria (Alzheimer's Disease or ALS)

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.

Exclusion Criteria:

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

Sites / Locations

Cuimc / NypRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Health Volunteers

Patients with Neurodegenerative Disorders

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04575727

First Posted

September 29, 2020

Last Updated

April 10, 2022

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT04575727

Brief Title

Exploratory Evaluation of [11C]MPC6827

Official Title

Exploratory Evaluation of [11C]MPC6827 Pharmacokinetics With Positron Emission Tomography (PET)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 8, 2021 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Neurodegenerative diseases are conditions where the brain cells break down, causing mental and/or physical impairment. Alzheimer's Disease is a neurodegenerative disorder that affects millions of individuals and causes irreversible memory loss and cognitive impairment. Amyotrophic lateral sclerosis is also and incurable disorder that causes patients irreversible paralysis, which results in death due to inability to breath and suffocation. These disease have been shown to be associated with abnormalities in an important scaffolding called microtubules, a cellular structure that help support the shape of the cells. This study will explore an experimental imaging test to see if it can be used to help doctors identify early microtubule changes. The test involves the injection of a radioactive compound that has been shown to go to cells and bind to microtubules. Special cameras called Positron Emission Tomography (PET)/CT cameras will be used to allow doctors to view where the radioactive compound goes in the body, as this is the first time this radiolabeled agent is being used in humans. In this study, doctors will give the new compound to up to five healthy volunteers to see where it goes in the body of people who presumable have normal microtubule function. Then doctors will give [11C]MPC6827 to up to 30 additional subjects (healthy controls and patients with Alzheimers Disease or ALS) to focus on imaging the brain for extended times. The research-imaging drug in this study is [11C]MPC6827. The radioactive drug in this study is experimental, meaning it is not approved by the FDA and can only be used in research studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurodegenerative Diseases, Alzheimer Disease, Amyotrophic Lateral Sclerosis

Keywords

[11C]MPC6827

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Health Volunteers

Arm Type

Experimental

Arm Description

Arm Title

Patients with Neurodegenerative Disorders

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

[11C]MPC6827

Other Intervention Name(s)

[11C]MPC

Intervention Description

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

Primary Outcome Measure Information:

Title

Biodistribution of [11C]MPC6827

Description

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

Time Frame

up to 48 hours from injection

Title

Estimation of clearance of [11C]MPC6827

Description

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

Time Frame

Up to 48 hours from injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria (Healthy Volunteers) 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. Inclusion Criteria (Alzheimer's Disease or ALS) 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rodolfo Arevalo, BA

Phone

212-342-1683

ra2874@cumc.columbia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Akiva Mintz, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cuimc / Nyp

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rodolfo Arevalo, BA

ra2874@cumc.columbia.edu

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Final data analysis and conclusion will be submitted to scientific journals and made available for publication.

Learn more about this trial

Exploratory Evaluation of [11C]MPC6827

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