NCT05582200Recruiting
Selective PET Imaging of Astrocytes and Microglia in Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 71 (estimated)
- First submitted
- 7 Oct 2022
- Start date
- 20 Jan 2023
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- The Methodist Hospital Research Institute
- Diseases
- Alzheimer disease
- NCT number
- NCT05582200
What you commit to
- Study type: Observational
- Planned participants: 71
- From 20 Jan 2023 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- Current use of psychotropic or anti-epileptic medication.
- 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.
Other illness
- History of large stroke or brain trauma, multiple sclerosis or other brain disorder that, in the judgment of the PI may confound the study.
- Brain disorder, other than idiopathic headache.
- Current primary Axis I or II psychiatric disorder.
- Active cancer, metabolic encephalopathy, infection, cardiovascular disease.
- Active hematological, renal, pulmonary, endocrine or hepatic disorders, except for treated thyroid disease.
- 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.
Other
- Inability to undergo MRI or PET for any reason, including severe claustrophobia.
- Inability to undergo MRI or PET for any reason, including severe claustrophobia.
- Substance abuse during the past two years.
Who the study is looking for
- 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.
- 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.
Criteria the registry did not label
- Patients with Alzheimer's disease
Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Houston Methodist Research Institute Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.