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Imagens de PET de ciclooxigenases em doenças cerebrais neurodegenerativas

30 de outubro de 2026 atualizado por: National Institute of Mental Health (NIMH)

Estudo de Fase 1: PET Imaging de Ciclooxigenases em Doença Neurodegenerativa do Cérebro

Background:

About 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder. Many studies have found that inflammation in the brain contributes to these diseases. Researchers want to find a better way to measure this inflammation.

Objective:

To learn whether COX-1 and/or COX-2 is elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers.

Eligibility:

Adults age 18 years and older in good general health who have an adult-onset neurodegenerative dementia, such as AD, FTD, corticobasal syndrome, Huntington s disease, or MCI, ALS and healthy adult volunteers enrolled in protocols 01-M-0254 or 17-M-0181.

Design:

Participants will be screened with medical history, physical exam with vital signs, and lab tests. They will have a neuropsychological testing. Their heart function will be measured.

Participants will have a magnetic resonance imaging (MRI) scan. The MRI scanner is a metal tube surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the tube. The machine makes noise. Participants will get earplugs.

Participants will have 2 PET scans. They will be injected with the study drugs through an intravenous catheter placed in an arm vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A plastic mask will be molded to their head to keep them from moving. A thin plastic tube will be put into an artery at the wrist or elbow crease area. This will be used to draw blood during the scan.

Participants will have 2-5 study visits. Participation lasts 1 week to 4 months, depending on scheduling.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

Study Description:

This pilot/exploratory study will examine whether cyclooxygenase 1 (COX-1) and COX-2 are elevated in the brain of individuals with neurodegenerative brain disease compared to healthy volunteers.

Objectives:

Primary Objective: To determine whether COX-1 and/or COX-2 is elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers.

Secondary Objective:

1) To determine retest variability and reliability for each radioligand. 2) To evaluate the specific binding of [11C]PS13 to COX-1 in healthy subjects through blocking study using Ketoprofen, a COX-1 inhibitor

Endpoints:

Primary Endpoint: Measurement of COX-1 and COX-2 density in brain after PET scans with [11C]PS13 and [11C]MC1, respectively.

Secondary endpoint: 1) To measure whole-brain distribution volume (VT) of COX-1 and COX-2 in a retest setting; 2) To correlate VT with the presence of amyloid in Alzheimer s disease (AD) patients, mild cognitive impairment (MCI) patients and healthy volunteers (HV); 3) To calculate the specific binding of [11C]PS13 with a Lassen plot

Tipo de estudo

Intervencional

Inscrição (Estimado)

184

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

  • Nome: Tara N Turon, C.R.N.P.
  • Número de telefone: (301) 827-6599
  • E-mail: tara.turon@nih.gov

Locais de estudo

    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20892
        • Recrutamento
        • National Institutes of Health Clinical Center
        • Contato:
          • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
          • Número de telefone: TTY8664111010 800-411-1222
          • E-mail: prpl@cc.nih.gov

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 99 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

  • INCLUSION CRITERIA:

Patients: In order to be eligible to participate in this study, patients must meet all of the following criteria:

  1. Aged 18 or older.
  2. 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.
  3. Have been diagnosed by a neurologist or psychiatrist with MCI, ALS, PD, or an adult onset neurodegenerative dementia, such as AD (including amyloid negative subjects), FTD, corticobasal syndrome, or Huntington s disease.
  4. Be in good general health as evidenced by medical history and physical examination.
  5. Have 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.
  6. Agree to adhere to the lifestyle considerations.

Healthy volunteers: In order to be eligible to participate in this study, healthy volunteer subjects must meet all of the following criteria:

  1. Aged 18 or older.
  2. Female participants of childbearing potential must be using a medically acceptable means of contraception
  3. Able provide informed consent.
  4. Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.
  5. Be enrolled in 01-M-0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17-M-0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies
  6. Have 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.
  7. Agree to adhere to the lifestyle considerations.

EXCLUSION CRITERIA:

Both patients and healthy volunteers who meet any of the following criteria will be excluded from participation in this study:

  1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two-times the upper limit or even lower values in the investigator s judgment. Creatinine level >1.3 mg/dL
  2. Subjects should not have taken Non-Steroidal Anti-Inflammatory Drugs (NSAID) 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.
  3. Contraindications to ketoprofen, such as hypersensitivity to ketoprofen or history of upper or lower gastrointestinal bleeding.
  4. 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.
  5. Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).
  6. Are unable to travel to the NIH.
  7. 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.
  8. 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 patient and/or caregiver during the screening visit.
  9. Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life.
  10. Participants should not be under treatment with Aduhelm, nor should they have been treated in the past.
  11. 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).
  12. Pregnancy
  13. HIV infection
  14. Be NIMH staff or an NIH employee who is a subordinate/relative/co-worker of the investigators.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Diagnóstico
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: Only one arm

All subjects receive the same tests

Injected IV followed by PET scanning

Injected IV followed by PET scanning

Injected IV followed by PET scanning

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Measure the concentration of radioligands
Prazo: 1-2 days

Density of COX-1 and COX-2 in brain

1-2 days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Measure the retest variability and reliability of the radioligans
Prazo: 1-2 days

Density of COX-1 and COX-2 in brain

1-2 days

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Robert B Innis, M.D., National Institute of Mental Health (NIMH)

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

17 de agosto de 2021

Conclusão Primária (Estimado)

11 de abril de 2029

Conclusão do estudo (Estimado)

3 de outubro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

20 de maio de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de maio de 2020

Primeira postagem (Real)

21 de maio de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de outubro de 2026

Última verificação

29 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 200082
  • 20-M-0082

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

results will be shared

Prazo de Compartilhamento de IPD

18 months after closure of protocol to Clincialtrials.gov

Critérios de acesso de compartilhamento IPD

BTRIS

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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