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11C-Acetate PET/CT Imaging As a Biomarker of Amyloid-Induced Neuroinflammation

Primary Purpose

Mild Cognitive Impairment

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

11C-acetate

About this trial

This is an interventional diagnostic trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for amnestic MCI cohort:

Participants will be at least 65 years of age
Positive brain amyloid PET/CT scan within 6 months of study screening
Mini-mental status examination (MMSE) score ≥ 24 at screening visit
A brain MRI is required. If a brain MRI has been performed within 6 months of 11C-Acetate PET/CT and of adequate quality that scan may be used for the study analysis, subjects who do not have a brain MRI will undergo a brain MRI as a part of this study
Participants must identify a study partner who is willing to accompany the patient to study visits
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. If the patient is unable to provide informed consent, the patient's legal representative may consent on behalf of the patient but the patient will be asked to confirm assent.

Inclusion Criteria for Control cohort:

Participants will be at least 65 years of age
History of negative brain amyloid PET/CT scan within 6 months of study screening OR negative CSF analysis for AD biomarkers within 6 months of study screening
Mini-mental status examination (MMSE) > 27 at screening visit
A brain MRI is required. If a brain MRI has been performed within 6 months of enrollment to this study and of adequate quality that scan may be used for the study analysis, subjects who do not have a brain MRI will undergo a brain MRI as a part of this study
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria for both cohorts:

Inability to tolerate or contraindication to imaging procedures (PET/CT or MRI) in the opinion of an investigator or treating physician
History of stroke or other neurological disease that in the opinion of the investigator might interfere with evaluation of the 11C-Acetate scan
Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

Sites / Locations

University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Amnestic MCI cohort

Control cohort

Arm Description

Patients with Mild Cognitive Impairment (MCI) (up to 14) will be recruited primarily from the Penn Memory Center (PMC). Clinical diagnostic criteria (described in further detail in Study Procedures section) will be used to identify subjects who are meet criteria for amnestic MCI. Participants will receive injection of radioactive tracer 11C-acetate and complete a PET/CT scan.

Normal control subjects in the same age range (up to 6) will be recruited from a current ongoing study investigating neuroinflammation in late life depression and healthy controls, from the control group in which all subjects receive MRI and LP and from the PMC research cohort. Participants will receive injection of radioactive tracer 11C-acetate and complete a PET/CT scan.

Outcomes

Primary Outcome Measures

Evaluate whether 11C-acetate uptake is increased in amyloid positive Mild Cognitive Impairment (MCI) subjects compared to amyloid negative healthy controls

Secondary Outcome Measures

Correlate 11C-acetate uptake to areas of greater amyloid plaque burden quantified on Amyloid PET/CT

Compare 11C-acetate in areas of mildly elevated PET SUVR to areas with high or sub-threshold amyloid burden

Correlate 11C-acetate uptake to levels of inflammatory markers in CSF

Full Information

NCT ID

NCT02811744

First Posted

June 20, 2016

Last Updated

April 11, 2022

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT02811744

Brief Title

11C-Acetate PET/CT Imaging As a Biomarker of Amyloid-Induced Neuroinflammation

Official Title

11C-Acetate PET/CT Imaging As a Biomarker of Amyloid-Induced Neuroinflammation

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Terminated

Why Stopped

Funding issues.

Study Start Date

January 2017 (Actual)

Primary Completion Date

February 28, 2022 (Actual)

Study Completion Date

February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The proposed study aims to use 11C-acetate PET/CT to preliminarily test and validate methods for imaging astrocyte activation as an early indicator of neuroinflammation in Alzheimer's disease (AD). 11C-Acetate PET/CT has been shown to quantify astrocyte activation in vivo, but no reports have evaluated its potential in AD. The investigators propose to test 11C-Acetate PET/CT as a marker for astrocyte activation associated with pathologic amyloid deposition in AD. The investigators will compare binding between subjects with early stage AD and healthy controls. Further, the investigators will investigate the correlation between amyloid and acetate binding. If the investigators find increased astrocyte activation in response to cerebral amyloid by showing a group difference in brain acetate uptake between disease and controls or a strong correlation between acetate and amyloid PET/CT binding. Validating neuroinflammation markers in AD ultimately may guide therapeutic modulation of beneficial and damaging neuroinflammation to slow disease progression, as well as providing new insights into AD pathophysiology.

6. Conditions and Keywords

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

Mild Cognitive Impairment

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Amnestic MCI cohort

Arm Type

Experimental

Arm Description

Arm Title

Control cohort

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

11C-acetate

Intervention Description

Participants will receive injection of radioactive tracer 11C-acetate and complete a PET/CT scan.

Primary Outcome Measure Information:

Title

Evaluate whether 11C-acetate uptake is increased in amyloid positive Mild Cognitive Impairment (MCI) subjects compared to amyloid negative healthy controls

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Correlate 11C-acetate uptake to areas of greater amyloid plaque burden quantified on Amyloid PET/CT

Time Frame

7 days

Title

Compare 11C-acetate in areas of mildly elevated PET SUVR to areas with high or sub-threshold amyloid burden

Time Frame

7 days

Title

Correlate 11C-acetate uptake to levels of inflammatory markers in CSF

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for amnestic MCI cohort: Participants will be at least 65 years of age Positive brain amyloid PET/CT scan within 6 months of study screening Mini-mental status examination (MMSE) score ≥ 24 at screening visit A brain MRI is required. If a brain MRI has been performed within 6 months of 11C-Acetate PET/CT and of adequate quality that scan may be used for the study analysis, subjects who do not have a brain MRI will undergo a brain MRI as a part of this study Participants must identify a study partner who is willing to accompany the patient to study visits Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. If the patient is unable to provide informed consent, the patient's legal representative may consent on behalf of the patient but the patient will be asked to confirm assent. Inclusion Criteria for Control cohort: Participants will be at least 65 years of age History of negative brain amyloid PET/CT scan within 6 months of study screening OR negative CSF analysis for AD biomarkers within 6 months of study screening Mini-mental status examination (MMSE) > 27 at screening visit A brain MRI is required. If a brain MRI has been performed within 6 months of enrollment to this study and of adequate quality that scan may be used for the study analysis, subjects who do not have a brain MRI will undergo a brain MRI as a part of this study Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. Exclusion Criteria for both cohorts: Inability to tolerate or contraindication to imaging procedures (PET/CT or MRI) in the opinion of an investigator or treating physician History of stroke or other neurological disease that in the opinion of the investigator might interfere with evaluation of the 11C-Acetate scan Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ilya Nasrallah, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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11C-Acetate PET/CT Imaging As a Biomarker of Amyloid-Induced Neuroinflammation

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