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

NCT05582200 | Unknown FDA Drug

• 1 other identifier: PRO00030631
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammation occurs in many brain diseases including Alzheimer's disease. In Alzheimer's disease, amyloid starts accumulating decades before the start of forgetfulness. Basic scientists have reported that inflammation but not amyloid is linked to forgetfulness. When people pinch a finger, it gets swollen. Similar changes occur in brain from various causes. New medications are under development to help healing and prevent permanent damages in the brain. When people pinch a finger, they can check if the injury is healing or getting worse by watching. 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 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 brain.

Conditions

Alzheimer Disease; Healthy

Outcome Measures

Primary Outcomes (2)

• The level of monoamine oxidase-B

  Binding of PET tracer \[F-18\]SMBT-1 to monoamine oxidase-B

  At the time of the PET scan

• The level of translocator protein

  Binding of PET tracer \[C-11\]ER176 to translocator protein

  At the time of the PET scan

Study Arms (2)

Healthy subjects

Healthy subjects

Diagnostic Test: Positron Emission Tomography (PET) using two PET tracer under IND

Patients with Alzheimer's disease

Patients with Alzheimer's disease

Diagnostic Test: Positron Emission Tomography (PET) using two PET tracer under IND

Interventions

Positron Emission Tomography (PET) using two PET tracer under IND DIAGNOSTIC_TEST

Positron Emission Tomography

Healthy subjects; Patients with Alzheimer's disease

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and patients with Alzheimer's disease

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Research Institute

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Central Study Contacts

Masahiro Fujita

CONTACT

7134410803; mfujita@houstonmethodist.org

Johnavon Linton

CONTACT

jlinton2@houstonmethodist.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 17, 2022
• Study Start: January 20, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

US (1)