Imaging Inflammation in Alzheimer's Disease

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2022-12-31

Brief Summary

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This study is being done to learn about inflammation and amyloid in Alzheimer's disease. A type of brain scan called a PET scan is used measure 1) inflammation and 2) abnormal accumulation of a the amount of a certain protein fragment called beta-amyloid (plaques) in the brain. These are thought to be involved in Alzheimer's disease. The investigators will also perform brain MRI and do tests to measure the participants' memory and thinking.

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Detailed Description

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This study is being done to determine the relationship between inflammation, cognitive impairment, and amyloid burden in elderly subjects with different clinical and biomarker profiles of Alzheimer's disease (AD). Participants will undergo amyloid PET imaging with 18F-Florbetaben with target number of completers being 15 amyloid-positive elders with impairment, 15 amyloid-positive elders with normal cognition, 15 amyloid-negative elders with impairment, and 15 amyloid-negative elders with normal cognition. Subjects will undergo screen that includes neuropsychological testing, brain MRI, and PET imaging with 18F-florbetaben to define the above 4 groups. Subjects will have 11C-PBR28 PET imaging to measure the 18 kDa translocator protein (a marker of inflammation). Subjects will have the option to have lumbar puncture performed to measure CSF concentrations of amyloid,tau, phospho-tau, and inflammatory markers.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Amyloid-positive with cognitive impairment (AD)

Amyloid-positive patients who already have cognitive impairment at the time of enrollment.

Group Type EXPERIMENTAL

11C-PBR28

Intervention Type DRUG

11C-PBR28 is a PET radioligand that binds to the 18 kDa translocator protein (TSPO), a marker of inflammation. 11C-PBR28 has previously been administered in humans. 11C-PBR28 will be administered at activity of up to 20 mCi per injection.

18F-Florbetaben

Intervention Type DRUG

18F-Florbetaben (Neuraceq) has FDA approval for human use in evaluation of Alzheimer's disease. 18F-Florbetaben will be administered at activity up to 8.1 mCi per injection.

Lumbar puncture (optional)

Intervention Type PROCEDURE

Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.

Amyloid-positive without impairment (preclinical AD)

Cognitively normal subjects who are amyloid-positive

Group Type ACTIVE_COMPARATOR

11C-PBR28

Intervention Type DRUG

11C-PBR28 is a PET radioligand that binds to the 18 kDa translocator protein (TSPO), a marker of inflammation. 11C-PBR28 has previously been administered in humans. 11C-PBR28 will be administered at activity of up to 20 mCi per injection.

18F-Florbetaben

Intervention Type DRUG

18F-Florbetaben (Neuraceq) has FDA approval for human use in evaluation of Alzheimer's disease. 18F-Florbetaben will be administered at activity up to 8.1 mCi per injection.

Lumbar puncture (optional)

Intervention Type PROCEDURE

Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.

Amyloid-negative with cognitive impairment

Participants with cognitive impairment due to suspected non-AD pathophysiology

Group Type ACTIVE_COMPARATOR

11C-PBR28

Intervention Type DRUG

11C-PBR28 is a PET radioligand that binds to the 18 kDa translocator protein (TSPO), a marker of inflammation. 11C-PBR28 has previously been administered in humans. 11C-PBR28 will be administered at activity of up to 20 mCi per injection.

18F-Florbetaben

Intervention Type DRUG

18F-Florbetaben (Neuraceq) has FDA approval for human use in evaluation of Alzheimer's disease. 18F-Florbetaben will be administered at activity up to 8.1 mCi per injection.

Lumbar puncture (optional)

Intervention Type PROCEDURE

Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.

Amyloid-negative without impairment (normal aging)

Cognitively normal subjects who are amyloid-negative on PET, and lack signs of neurodegeneration from other biomarkers

Group Type ACTIVE_COMPARATOR

11C-PBR28

Intervention Type DRUG

11C-PBR28 is a PET radioligand that binds to the 18 kDa translocator protein (TSPO), a marker of inflammation. 11C-PBR28 has previously been administered in humans. 11C-PBR28 will be administered at activity of up to 20 mCi per injection.

18F-Florbetaben

Intervention Type DRUG

18F-Florbetaben (Neuraceq) has FDA approval for human use in evaluation of Alzheimer's disease. 18F-Florbetaben will be administered at activity up to 8.1 mCi per injection.

Lumbar puncture (optional)

Intervention Type PROCEDURE

Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.

Interventions

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11C-PBR28

11C-PBR28 is a PET radioligand that binds to the 18 kDa translocator protein (TSPO), a marker of inflammation. 11C-PBR28 has previously been administered in humans. 11C-PBR28 will be administered at activity of up to 20 mCi per injection.

Intervention Type DRUG

18F-Florbetaben

18F-Florbetaben (Neuraceq) has FDA approval for human use in evaluation of Alzheimer's disease. 18F-Florbetaben will be administered at activity up to 8.1 mCi per injection.

Intervention Type DRUG

Lumbar puncture (optional)

Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.

Intervention Type PROCEDURE

Other Intervention Names

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11C-[O-methyl-11C]N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine Neuraceq LP

Eligibility Criteria

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Inclusion Criteria

1. Age 60 and older.
2. Meet criteria for either a) amnestic mild cognitive impairment (single or mixed domain) or mild Alzheimer's disease, or b) have no cognitive impairment based on history, exam, neuropsychological testing, and consensus diagnosis. MCI and mild AD patients must have Clinical Dementia Rating scale score of 0.5 or 1. Unimpaired subjects must have Clinical Dementia Rating scale score of 0.
3. Subjects unable to provide informed consent must have a surrogate decision maker
4. Written and oral fluency in English or Spanish.
5. Able to participate in all scheduled evaluations and to complete all required tests and procedures.
6. In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.

Exclusion Criteria

1. Past or present history of certain brain disorders other than MCI or AD.
2. Certain significant medical conditions, which make study procedures of the current study unsafe.
3. Contraindication to MRI scanning.
4. Conditions precluding entry into the scanners (e.g., morbid obesity, claustrophobia, etc.).
5. Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.
6. Low affinity binding on TSPO genetic screen.
7. Participation in the last year in a clinical trial for a disease modifying drug for AD.
8. Inability to have a catheter in subject's vein for the injection of radioligand.
9. Inability to have blood drawn from subject's veins.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes