Imaging brain inflammation in Alzheimer's disease

Selective PET Imaging of Astrocytes and Microglia in Alzheimer's Disease

This study is testing a new imaging technique to see if it can help us understand brain inflammation in people with Alzheimer's disease compared to healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 71 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: The Methodist Hospital Research Institute (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05582200 on ClinicalTrials.gov

What this trial studies

This study investigates the role of inflammation in Alzheimer's disease by using a specialized imaging technique called positron emission tomography (PET). It aims to improve the specificity of imaging by utilizing a novel tracer, 18F-SMBT-1, which selectively targets astrocytes, a type of brain cell involved in neuroinflammation. The study will involve healthy participants and patients with Alzheimer's disease to assess the binding properties of the tracer and its potential to provide clearer insights into brain inflammation. By comparing the levels of a specific enzyme, MAO-B, between healthy individuals and Alzheimer's patients, the study seeks to enhance our understanding of the disease's progression.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 50-90 who have been diagnosed with Alzheimer's disease and meet specific cognitive criteria.

Not a fit: Patients with severe claustrophobia or other significant brain disorders may not benefit from this study due to the imaging requirements.

Why it matters

Potential benefit: If successful, this study could lead to more accurate imaging techniques that help monitor and treat Alzheimer's disease more effectively.

How similar studies have performed: While previous studies have utilized TSPO imaging, this approach with the novel tracer 18F-SMBT-1 is relatively novel and aims to provide more specific insights into astrocytic activity in Alzheimer's disease.

Eligibility criteria

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.

Where this trial is running

Houston, Texas

• Houston Methodist Research Institute — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Joseph C. Masdeu, MD, PhD

Conditions Alzheimer Disease; Healthy