Recruiting

Adverse InflammationSelective PET Imaging of Astrocytes and Microglia in Alzheimer's Disease

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT05582200

Conditions

Alzheimer Disease

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Positron Emission Tomography (PET) using 11C-ER176 for TSPO and 18F-SMBT1 for MAO-B

Study Details

Brief summary:

Inflammation occurs in many brain diseases including Alzheimer's disease. In Alzheimer's disease, an abnormal protein called amyloid starts accumulating decades before the start of forgetfulness. However, scientists have reported that inflammation but not amyloid is linked to forgetfulness and the topography of brain inflammation and tau buildup are closely correlated in patients with mild cognitive impairment due to Alzheimer's disease. New medications are under development to help healing and prevent permanent damage in the brain. To see if inflammation is improving or getting worse with these medications, investigators can watch inside of the brain using a special camera called positron emission tomography (PET). It is currently possible to watch inflammation in the brain by taking pictures of a molecule called translocator protein (TSPO). But the problem is that by imaging TSPO, investigators can catch changes in more than one kind of cells. The information is not specific to each cell type. Such vague information is not completely useful to monitor the effect of new medications for inflammation. This proposal attempts to develop a novel method to capture changes in each of two major players in inflammation, microglia and astrocytes. To do so, investigators will take selective pictures of one cell type by using a novel imaging agent for PET. Investigators will also take PET pictures of TSPO. Investigators will process these two kinds of PET pictures using advanced mathematical methods and extract specific information on microglia and astrocytes. Our novel method will be useful to monitor new therapies to treat inflammation in the brain.

Conditions

Alzheimer Disease

Healthy

Study ID

NCT05582200

Start date

Jan 20, 2023

Status verified date

Mar, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Patients with Alzheimer's disease

Inclusion criteria:

Individuals of either sex, 50-90 years of age.
Meeting research criteria for AD (McKhann, Knopman et al. 2011).
With a CDR (Morris 1993) score of 1-3.
Fluent in English or Spanish.
Have sufficient communication and comprehension ability to consent to the performance of the study or have a legally authorized representative.

Exclusion criteria:

Inability to undergo MRI or PET for any reason, including severe claustrophobia.
History of large stroke or brain trauma, multiple sclerosis or other brain disorder that, in the judgment of the PI may confound the study.
Pregnancy. In women in whom the possibility of pregnancy cannot be excluded, a pregnancy test must be performed on site the morning of any PET visit and a negative result together with a physician interview are required prior to the administration or any radiopharmaceutical.
Research radiation exposure greater than 50 mSv effective dose within 12 months including radiation exposure from this study.

Healthy volunteers:

Inclusion criteria:

Individuals of 18-90 years of age.
Negative amyloid accumulation determined by PET (only for the comparison with AD).
Fluent in English.
Have enough communication and comprehension ability to consent to the performance of the study.

Exclusion criteria:

Inability to undergo MRI or PET for any reason, including severe claustrophobia.
Brain disorder, other than idiopathic headache.
Current primary Axis I or II psychiatric disorder.
Current use of psychotropic or anti-epileptic medication.
Substance abuse during the past two years.
Active cancer, metabolic encephalopathy, infection, cardiovascular disease.
Active hematological, renal, pulmonary, endocrine or hepatic disorders, except for treated thyroid disease.
Pregnancy. In women in whom the possibility of pregnancy cannot be excluded, a pregnancy test must be performed on site the morning of any PET visit and a negative result together with a physician interview are required prior to the administration or any radiopharmaceutical
Research radiation exposure greater than 50 mSv effective dose within 12 months including radiation exposure from this study.
Only for the subjects undergoing the blocked scan with selegiline: known contraindications to selegiline, including hypersensitivity to the drug and use of opioids, such as meperidine and some antidepressants such as bupropion.

Study Design

Enrollment

71 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy subjects

Patients with Alzheimer's disease

Interventions

Positron Emission Tomography (PET) using 11C-ER176 for TSPO and 18F-SMBT1 for MAO-B

Participants will receive PET with 11C-ER176 to measure microglia AND astrocytes and PET with 18F-SMBT1 to measure astrocytes.

Primary outcome measure

The level of monoamine oxidase-B [ Time Frame: At the time of the PET scan ]
The level of translocator protein [ Time Frame: At the time of the PET scan ]

Central Contacts and Locations

Central contacts

Joseph C. Masdeu, MD, PhD

7134411150 jcmasdeu@houstonmethodist.org

Belen Pascual, PhD

7134411150 bpascual@houstonmethodist.org

Locations

Houston Methodist Research Institute

Recruiting

Houston, Texas, United States, 77030

Contacts

Joseph C. Masdeu, MD, PhD

713-441-1150 jcmasdeu@houstonmethodist.org

Belen Pascual, PhD

7134411150 bpascual@houstonmethodist.org

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Apr 6, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-04-06.