Selective PET Imaging of Astrocytes and Microglia in Alzheimer's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorThe Methodist Hospital Research Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Healthy volunteers and patients with Alzheimer's disease
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Positron Emission Tomography (PET) using 11C-ER176 for TSPO and 18F-SMBT1 for MAO-B
DrugParticipants will receive PET with 11C-ER176 to measure microglia AND astrocytes and PET with 18F-SMBT1 to measure astrocytes.
Treatment groups
71 Participants
are divided into 2 treatment groupsGroup A: Healthy subjects1 intervention
Group B: Patients with Alzheimer's disease1 intervention
Trial outcomes
Primary outcomes
1
The level of monoamine oxidase-B
Binding of PET tracer \[F-18\]SMBT-1 to monoamine oxidase-B
Time frame
At the time of the PET scan2
The level of translocator protein
Binding of PET tracer \[C-11\]ER176 to translocator protein
Time frame
At the time of the PET scanSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov