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Résztvevőt keres itt: Egyesült Államok1. fázis

PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)

A legfontosabb adatok

Ki végzi
National Institute of Mental Health (NIMH)
Hol
Bethesda (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Toboroz
Fázis
1. fázis
Résztvevők
90 fő, tervezett
Kezdés
2026. nov. 17.
Várható befejezés
2030. ápr. 11.
A vizsgálat típusa
Beavatkozással járó
A vizsgált kezelések
  • 18F-PF974
  • 18F-florbetaben
A regiszteradat frissítve
2026. november 12.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat 50 éves vagy idősebb, Alzheimer-kórral vagy enyhe kognitív zavarral élő embereket keres, valamint egészséges önkénteseket. Az agyi PET-vizsgálatokkal a PDE4B nevű enzimet vizsgálják.

Életkor
50–100 év
Nem
Mindkét nem
A betegség stádiuma
Alzheimer-kór vagy enyhe kognitív zavar, amelyet neurológus vagy pszichiáter állapított meg. Az egészséges önkénteseknek nem lehet kognitív zavara.
Korábbi kezelés
A PET-vizsgálat előtt két hétig nem szedhettek NSAID-ot. Az előző hónapban nem szedhettek aszpirint, kortikoszteroidot (a bőrre kenhető készítmények kivételével) vagy immunszuppresszánst. Nem kaphatnak és nem kaptak korábban amiloid elleni antitestet, például lekanemabot.

A részvétel fő kizáró okai

  • Terhesség vagy szoptatás
  • HIV-fertőzés
  • Szerhasználati vagy alkoholhasználati zavar
  • Nem végezhető el rajta MRI-vizsgálat, például pacemaker vagy fém implantátum miatt
  • Nem beszél angolul

A regiszter feltételei, szó szerint

Mind a 26 feltétel megnézéseKevesebb

Ki nem vehet részt

  • Participants should not have taken non-steroidal anti-inflammatory drugs (NSAIDs) for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of skin products), or immunosuppressants (e.g., methotrexate) must not have been taken in the prior month
  • 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
  • Participants should not be under treatment or previously treated with an amyloid antibody such as lecanemab
  • 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; Exclusion of Pregnant or Breastfeeding Women:; Pregnant women will be excluded because this protocol involves exposure to ionizing radiation. Lactating women will be excluded because radioisotopes may be excreted in milk. We will not require contraception for this protocol to allow participants autonomy in medical decision-making. However, while we will not require contraception for woman of childbearing potential, we will perform a pregnancy test at screening and prior to all procedures to ensure participants are not pregnant; Exclusion of Participants who are HIV Positive:; Persons with HIV infection are excluded because HIV infection itself may change cAMP signaling; Exclusion of Non-English-Speaking Participants:; Non-English-speaking participants will be excluded from participation in this study because neuropsychological testing is required by this protocol. This testing, which is critical for interpreting study results, has not been validated in other languages or when using a translator
  • 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 neurological abnormalities
  • Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy)
  • Participants must not have substance use disorder or alcohol use disorder
  • 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 (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye)
  • HIV infection
  • Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen)
  • Both the study groups will be excluded if they meet any of the following criteria:
  • Are unable to travel to the NIH
  • 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 be screened by an interview with the volunteer and/or caregiver during the screening visit
  • Pregnancy or breast feeding

Egyéb feltételek

  • INCLUSION CRITERIA:; Participants will be referred by a physician with the suspected diagnosis of AD or MCI. However, the PI of this protocol will provide the final diagnosis. For this reason, this protocol will have just one consent form for participants suspected of having either AD or MCI; AD and MCI Study Groups:; Participants must meet all the following 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
  • Agree to adhere to the lifestyle considerations; Healthy Volunteers:; Participants must meet all the following criteria:
  • 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

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 50 és 100 év között vagy?

Helyszínek itt: Egyesült Államok

  • National Institutes of Health Clinical CenterBethesda, Egyesült ÁllamokContact: NIH Clinical Center Office of Patient Recruitment (OPR)Résztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

Background:

A teljes eredeti leírásKevesebb

About 5 million adults in the United States have age-related brain disorders. These include Alzheimer disease (AD), mild cognitive impairment (MCI), and other dementias. The number of people with these disorders will likely increase as the population ages and life span increases. Inflammation is thought to play a role in AD and MCI. Researchers want to know if an enzyme called PDE4B increases inflammation in people with AD or MCI.

Objective:

To test whether medical imaging using a new radiotracer ([18F]PF-06445974) can measure PDE4B in the brains of people with AD or MCI.

Eligibility:

People aged 50 years and older with AD or MCI. Healthy volunteers are also needed.

Design:

Participants will have up to 5 clinic visits with 3 imaging scans of the brain.

They will have be screened. They will have a physical exam with blood tests. This will include tests of their heart and nerve function, including memory.

Participants will have 2 positron emission tomography (PET) scans. One will use a standard radiotracer. The other will use the study radiotracer. They will receive each tracer through a tube attached to a needle inserted into a vein. During the scan with the study tracer, participants will have a second tube inserted into a vein in the wrist; this tube will be used to draw blood during the scan. Participants will lie on a bed that slides into a doughnut-shaped machine. These visits will take about 6 hours each.

Participants will have 1 magnetic resonance imaging (MRI) scan. They will lie on a bed that slides into a cylinder. This visit will take up to 2 hours....

A vizsgálat csoportja

  • One-ArmEgyéb csoport

    All subjects will receive the same tests.

    Kezelés: 18F-PF974 és 18F-florbetaben

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer s Disease (AD) or Mild Cognitive Impairment (MCI)
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
Illeszkedési kérdések
Forrás: NCT07169630: ki vehet részt
A regiszteradat frissítve
2026. november 12.