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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a new way to use PET brain scans to measure changes in two types of brain cells involved in inflammation: microglia and astrocytes. It is for people ages 50–90 with Alzheimer's disease and healthy volunteers ages 18–90. The goal is to help track how future treatments affect brain inflammation.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • People with Alzheimer's: Ages 50–90 and meet the study's research rules for Alzheimer's disease.
  • People with Alzheimer's: Have a Clinical Dementia Rating (CDR) score of 1–3, a measure of how much dementia affects daily life.
  • People with Alzheimer's: Speak English or Spanish fluently.
  • People with Alzheimer's: Can understand and agree to the study, or have a legally approved person who can agree for them.
  • Healthy volunteers: Ages 18–90 and speak English fluently.
  • Healthy volunteers: Can understand and agree to the study.
  • Healthy volunteers being compared with the Alzheimer's group: A PET scan must show no buildup of amyloid, a protein linked to Alzheimer's.

Who can't join

  • Both groups: Cannot have MRI or PET scans for any reason, including a strong fear of closed spaces.
  • Both groups: Are pregnant. If pregnancy is possible, a negative pregnancy test and doctor interview are needed on the morning of each PET visit before the scan drug is given.
  • Both groups: Research radiation exposure, including this study, would be more than 50 mSv within 12 months. This is a measure of radiation dose.
  • People with Alzheimer's: Have had a large stroke, brain injury, multiple sclerosis, or another brain disorder that the lead researcher thinks could affect study results.
  • Healthy volunteers: Have a brain disorder other than headaches with no known cause, a current mental health or personality disorder covered by the study's rules, or substance abuse in the past 2 years.
  • Healthy volunteers: Currently take medicine for mental health conditions or seizures.
  • Healthy volunteers: Have active cancer, an infection, heart or blood vessel disease, brain problems caused by chemical changes in the body, or a blood, kidney, lung, hormone, or liver disorder. Treated thyroid disease is allowed.
  • Healthy volunteers having a scan with selegiline: Have a reason they cannot safely take this drug, such as an allergy or use of opioids like meperidine or certain antidepressants like bupropion.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TX