Alzheimer s Disease study: 18F-PF974 vs 18F-florbetaben
Official title PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
ClinicalTrials.gov ID: NCT07169630
What this study is testing
What is 18F-PF974?
This is an investigational imaging agent being studied to help measure a specific protein in the brains of people with Alzheimer's disease or mild cognitive impairment.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if a new PET imaging tracer can detect the enzyme PDE4B, which may increase inflammation in Alzheimer’s and mild cognitive impairment.
- Who it's for
- Adults 50 years or older who have Alzheimer’s disease or mild cognitive impairment, plus healthy volunteers.
- What's involved
- Participants will have up to five clinic visits, including three brain PET scans (one with a standard tracer and one with the study tracer), a blood draw during the study scan, a physical exam with blood tests, heart and nerve function tests, and a memory test. One visit will also include an MRI scan.
- Time commitment
- The study lasts about 6 hours per visit for the PET scans and up to 2 hours for the MRI, with a total of up to five visits.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 100. Healthy volunteers may be eligible.
You may be able to join if
- Aged 50 or older.
- Be able (or have their Legally Authorized Representative (LAR) be able) to understand the study and be willing to sign a written informed consent...
- Have been diagnosed by a neurologist or psychiatrist with MCI or AD.
- Be in good general health as evidenced by medical history and physical examination.
- Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both...
You likely can't join if
- Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea...
- Participants should not have taken non-steroidal anti-inflammatory drugs (NSAIDs) for two weeks prior to the PET scan.
- Have other major neurological or medical diseases that may cause cognitive dysfunction, such as structural brain diseases, metabolic diseases...
- Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated...
- Are unable to travel to the NIH.
- Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the...
See the full eligibility criteria
- Aged 50 or older.
- Be able (or have their Legally Authorized Representative (LAR) be able) to understand the study and be willing to sign a written informed consent document.
- Have been diagnosed by a neurologist or psychiatrist with MCI or AD.
- Be in good general health as evidenced by medical history and physical examination.
- Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.
- Aged 50 or older.
- Able to provide informed consent.
- Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.
- Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.
- Agree to adhere to the lifestyle considerations.
- Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).
- Participants should not have taken non-steroidal anti-inflammatory drugs (NSAIDs) for two weeks prior to the PET scan.
- Have other major neurological or medical diseases that may cause cognitive dysfunction, such as structural brain diseases, metabolic diseases, paraneoplastic syndromes, infectious diseases, or other significant...
- Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).
- Are unable to travel to the NIH.
- Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.
- Have an inability to lie flat and/or lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will...
- Participants must not have substance use disorder or alcohol use disorder.
- Participants should not be under treatment or previously treated with an amyloid antibody such as lecanemab.
- Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses...
- Pregnancy or breast feeding.
- HIV infection.
- Non-English speaking participants. Exclusion of Children: Inclusion of children is not appropriate, because this protocol has more than minimal risk from radiation exposure without the possibility of direct benefit.
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 100 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.