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

Plain English Summary

Selective PET Imaging of Astrocytes and Microglia in Alzheimer's Disease is a Not Applicable clinical trial sponsored by The Methodist Hospital Research Institute studying Alzheimer Disease, Healthy. This study tests a new way to see and measure inflammation in the brain using special PET scans. It is for people with Alzheimer's disease and healthy volunteers who can help compare results. Participation involves undergoing PET scans and possibly MRI scans, with some tests before and after. Currently, it's hard to precisely measure brain inflammation; this study aims to improve that. The trial aims to enroll 71 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. People with Alzheimer's disease aged 50-90 who have mild to moderate cognitive impairment and can communicate well. Healthy volunteers aged 18-90 who do not have amyloid buildup in their brain and can communicate well. You cannot join if you have had a major stroke, brain injury, or other brain conditions that could affect the results. You also cannot join if you are pregnant, have severe claustrophobia, or have had too much radiation exposure recently. This trial is studying Alzheimer Disease, Healthy, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure levels of specific proteins in the brain, helping researchers understand how inflammation is changing and if new treatments are working. The specific primary outcome measures are: The level of monoamine oxidase-B (At the time of the PET scan); The level of translocator protein (At the time of the PET scan). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to develop a more precise way to monitor brain inflammation, which is crucial for developing and testing new treatments for Alzheimer's disease. This research targets Alzheimer Disease, Healthy, where improved treatment options are needed.

Investor Insight

This trial signals a focus on advanced imaging techniques for neurodegenerative diseases, a growing market with significant unmet needs, suggesting potential for improved diagnostic and therapeutic mo

Is This Trial Right for Me?

Ask your doctor if this new imaging technique is right for you and what the scans involve. You will have PET scans to look at brain inflammation and possibly MRI scans. Some tests will be done before and after the scans. The study involves multiple visits for scans and assessments over its duration. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 71 participants

Interventions

• DRUG: 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 Outcomes

• The level of monoamine oxidase-B (At the time of the PET scan)
• The level of translocator protein (At the time of the PET scan)

Full 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.

Trial Locations

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

Frequently Asked Questions

Related Conditions

• Alzheimer Disease
• Mild Cognitive Impairment
• Neuroinflammation
• Brain Imaging
• Positron Emission Tomography (PET)
• Magnetic Resonance Imaging (MRI)
• Microglia
• Astrocytes
• Tauopathy
• Amyloidosis

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