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RecruitingPhase 2

Longitudinal Imaging of Microglial Activation in Different Clinical Variants of 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
50 Years and older
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

  • Procedures mentioned: PET scans, Spinal tap (lumbar puncture), MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "A PET scan uses very small amounts of a radioactive drug that is injected into a vein to create a special picture of the brain."
  • "The inflammation PET scan uses a drug called ER176."
  • "Once in the body, ER176 sticks to areas with lots of inflammation, and the PET scan allows us to see these areas."
  • "In order to measure these proteins in the spinal fluid, the investigators need to perform a lumbar puncture (spinal tap)."
  • "The investigators can measure these proteins using PET scans."
  • "The amyloid PET scan uses a drug called florbetaben that has been approved by the FDA to help diagnose Alzheimer's disease."
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 looks at how brain inflammation (swelling) relates to brain changes and early symptoms of Alzheimer's disease. It includes adults age 50 and older with different forms of Alzheimer's or related memory and thinking problems, as well as older adults with normal vision, language, and memory skills.

The purpose of this study is to determine how inflammation is related to other changes in the brain that occur during the progression of Alzheimer's disease. The investigators are also studying how inflammation is related to the symptoms that first occur in patients with Alzheimer's disease (AD). For this reason, the investigators are asking people with different versions of Alzheimer's disease and/or other related dementias to participate. This includes patients with: * Mild Cognitive Impairment * Posterior cortical atrophy - a version of Alzheimer's disease with vision difficulties * Logopenic variant primary progressive aphasia - a version of Alzheimer's disease with language difficulties * Amnestic Alzheimer's disease - a "typical" version of Alzheimer's disease with memory difficulties * The investigators are also enrolling older adults with normal visual, language, and memory function.

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

Eligibility

Who can join

  • Be age 50 or older at screening.
  • Have no thinking or memory problems, or have Alzheimer's that mainly affects memory, vision, or language. The study team will confirm this with exams, tests, and a brain scan.
  • People with Alzheimer's must have a dementia rating score of 0.5 or 1, meaning very mild or mild problems. Those without thinking or memory problems must score 0.
  • If you cannot give informed consent, have someone who can make that decision for you.
  • Be fluent in spoken and written English or Spanish.
  • Be able to attend all planned visits and complete all required tests and procedures.
  • The lead researcher must believe you are likely to follow the study plan and finish the study.

Who can't join

  • Have or have had a brain disorder other than Alzheimer's, including certain stroke damage seen on a brain scan, even without stroke symptoms.
  • Have a serious health condition that makes study procedures unsafe, such as uncontrolled seizures or several serious injuries.
  • Cannot safely have an MRI brain scan.
  • Cannot enter or stay in the scanners, for example because of very high body weight or fear of small, closed spaces.
  • Had radiation from research in the past year that, together with this study, would go over allowed limits.
  • Take medicines that the lead researcher and consulting doctor decide are not allowed.

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

Official eligibility criteria

Inclusion criteria: 1. Age 50 and over at time of screening. 2. At screening, must have no cognitive impairment, or meet criteria for amnestic Alzheimer's disease, posterior cortical atrophy, or logopenic variant primary progressive aphasia. Diagnoses will be made based on history, exam, neuropsychological testing, brain MRI, and consensus diagnosis. 3. Patients must have Clinical Dementia Rating scale score of 0.5 or 1 at enrollment. Controls must have Clinical Dementia Rating scale score of 0 at enrollment. 4. Subjects unable to provide informed consent must have a surrogate decision maker. 5. Written and oral fluency in English or Spanish. 6. Able to participate in all scheduled evaluations and to complete all required tests and procedures. 7. In the opinion of the PI, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study. Exclusion criteria: 1. Past or present history of a brain disorder other than Alzheimer's disease (including presence of cortical infarct on MRI even in absence of clinical stroke). 2. Serious medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries. 3. Contraindication to MRI scanning. 4. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.). 5. Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits. 6. Exact medication exclusions are up to the discretion of the PI in consultation with the MD liaison.

Study sites (1)

NY