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Multimodal Biomarkers for Diagnosis and Prognosis in VCI (VCI)

26. oktober 2020 opdateret af: National Taiwan University Hospital

Multimodal Biomarkers for Diagnosis and Prognosis in Vascular Cognitive Impairment

We will try to

  1. establish the correlation of plasma Aβ40 and Aβ42 level, ApoE genotype, MRI imaging markers in the diagnosis and prognosis of VCI patients
  2. understand more on the pathophysiology of VCI.

Studieoversigt

Status

Rekruttering

Intervention / Behandling

Detaljeret beskrivelse

Background and objectives Owing to the aging problem, cognitive impairment has been a worldwide health issue. Vascular cognitive impairment (VCI) and Alzheimer's disease (AD) are the two most common causes. It has been reported that VCI and AD share many common risk factors. MRI is essential in assessing the extent, location and type of vascular lesions. Amyloid PET has been used in detecting cerebral amyloid burden non-invasively since 2004. There are only small number of studies using amyloid PET in VCI and the results are still controversial. In the current proposal, we will investigate

  1. the correlation of clinical risk factors, ApoE genotype, various MRI markers, and amyloid PET expression
  2. assess the influence of ApoE genotype on different biomarkers, including MRI markers, amyloid retention, and plasma Aβ40 and Aβ42 levels
  3. the potential of amyloid PET as a prognostic factor for VCI patients.

Materials and methods This study will be conducted in National Taiwan University Hospital and Bei-Hu Branch Hospital. Sixty clinical diagnosed VCI, 30 AD patients and 30 normal subjects will be enrolled in this 3-year prospective study. We will collect vascular risk factors, neuropsychological tests, 10 cc venous blood for plasma Aβ40, Aβ42, total tau and phosphorylated level measurement by IMR assay, ApoE genotype, brain MRI, and amyloid PET of each patient and control subject. All the data will be analyzed together.

Expected Results We will try to

  1. establish the correlation of plasma Aβ40 and Aβ42 level, ApoE genotype, MRI imaging markers in the diagnosis and prognosis of VCI patients
  2. understand more on the pathophysiology of VCI.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Taipei, Taiwan, 100
        • Rekruttering
        • National Taiwan Univeristy Hospital
        • Kontakt:
          • Yen Ruoh Fang, MD, PhD
          • Telefonnummer: 65581 886-2-23123456
          • E-mail: rfyen@ntu.edu.tw

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

-

I. Vascular cognitive impairment patients:

  1. Age older than 20 years.
  2. Clinical diagnosis:

    1. At least one obstacle to executive function, attention, memory, language and visual space function.
    2. Affected activities of daily living.
    3. Brain MRI showing cerebrovascular disease.
  3. Patient agrees to participate in the study and is willing to receive 11C-PiB PET.

II. Alzheimer's disease (AD) patients:

  1. Age older than 20 years.
  2. Clinical diagnosis:

    1. Amnesia or non-amnesia (language, visual space, executive ability) performance.
    2. Affected activities of daily living.
  3. Patient agrees to participate in the study and is willing to receive 11C-PiB PET.

III. Normal controls:

  1. Age older than 20 years.
  2. No neurological or psychiatric history.
  3. Patient agrees to participate in the study and is willing to receive 11C-PiB PET.

Exclusion Criteria:

-

I. Vascular cognitive impairment patients:

  1. Have other illnesses, including people with drug / alcohol abuse / addictivity within three months.
  2. Patient cannot accept brain magnetic resonance imaging or 11C-PiB PET, such as agitation and inability to cooperate, allergy to contrast agents, hemodynamic instability (blood pressure, pulse, or blood oxygen is not in the normal range), and a heart rhythm regulator has been implanted , Have ever undergone intracranial aneurysm clamp surgery, claustrophobia and hemodynamic instability.
  3. Pregnant woman or intends to be pregnant in the near future.
  4. Patient who is breast feeding or intends to.
  5. Allergic to 11C-PiB, or with severe drug allergy history.
  6. Patient or the family refuses to participate in the study.

II. Alzheimer's disease (AD) patients:

  1. Have other illnesses, including:

    1. Cognitive disorders caused by cerebrovascular diseases (the decline in cognitive function is closely related to the time of stroke, multiple large-scale necrosis, and severe white matter lesions).
    2. The main manifestation of dementia is Lewy body dementia
    3. Symptoms are behavioral variation of frontotemporal dementia.
    4. The symptoms are obviously semantic progressive aphasia.
    5. Symptoms are not fluent in primary progressive aphasia.
    6. Other comorbidities that affect cognitive function (including other active neurological diseases, or non-neurological diseases but the disease or the treatment used will affect cognitive function)
  2. Patient cannot accept brain magnetic resonance imaging or 11C-PiB PET, such as agitation and inability to cooperate, allergy to contrast agents, hemodynamic instability (blood pressure, pulse, or blood oxygen is not in the normal range), and a heart rhythm regulator has been implanted , Have ever undergone intracranial aneurysm clamp surgery, claustrophobia and hemodynamic instability.
  3. Pregnant woman or intends to be pregnant in the near future.
  4. Patient who is breast feeding or intends to.
  5. Allergic to 11C-PiB, or with severe drug allergy history.
  6. Patient or the family refuses to participate in the study.

III. Normal controls:

  1. Patient cannot accept brain magnetic resonance imaging or 11C-PiB PET, such as agitation and inability to cooperate, allergy to contrast agents, hemodynamic instability (blood pressure, pulse, or blood oxygen is not in the normal range), and a heart rhythm regulator has been implanted , Have ever undergone intracranial aneurysm clamp surgery, claustrophobia and hemodynamic instability.
  2. Pregnant woman or intends to be pregnant in the near future.
  3. Patient who is breast feeding or intends to.
  4. Allergic to 11C-PiB, or with severe drug allergy history.
  5. Patient or the family refuses to participate in the study.
  6. high risk as assessed by a doctor.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: amyloid PET, T807 PET
PET/CT
Dynamic PET acquisition for 70 minutes will be acquired after injection of 10±5 mCi 11C-PiB.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PET billeddannelse
Tidsramme: på 3 dage
PET-data vil rekonstruere med ordnet set forventningsmaksimering, korrigeret for dæmpning, og hver frame vil blive evalueret for at verificere passende tællestatistikker og fravær af hovedbevægelse.
på 3 dage

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. september 2020

Primær færdiggørelse (Forventet)

31. juli 2023

Studieafslutning (Forventet)

31. juli 2023

Datoer for studieregistrering

Først indsendt

21. oktober 2020

Først indsendt, der opfyldte QC-kriterier

26. oktober 2020

Først opslået (Faktiske)

27. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med amyloid PET

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