Imaging brain inflammation in Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Houston Methodist Research Institute
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Joseph C. Masdeu, MD, PhD
• Email: jcmasdeu@houstonmethodist.org
• Phone: 7134411150

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.