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



Status:Recruiting
Conditions:Cognitive Studies, Cognitive Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:65 - Any
Updated:7/5/2018
Start Date:January 2017
End Date:June 2024
Contact:Jenny Cai
Email:jenny.cai@uphs.upenn.edu
Phone:215-898-4346

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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.


Inclusion Criteria for amnestic MCI cohort:

1. Participants will be at least 65 years of age

2. Positive brain amyloid PET/CT scan within 6 months of study screening

3. Mini-mental status examination (MMSE) score ≥ 24 at screening visit

4. 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

5. Participants must identify a study partner who is willing to accompany the patient to
study visits

6. 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:

1. Participants will be at least 65 years of age

2. 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

3. Mini-mental status examination (MMSE) > 27 at screening visit

4. 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

5. 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:

1. Inability to tolerate or contraindication to imaging procedures (PET/CT or MRI) in the
opinion of an investigator or treating physician

2. History of stroke or other neurological disease that in the opinion of the
investigator might interfere with evaluation of the 11C-Acetate scan

3. Any medical or psychological conditions that, in the opinion of the investigator,
would compromise the subject's safety or successful participation in the study.
We found this trial at
1
site
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-898-4346
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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