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Biomarkers and Early Alzheimer's Disease

16. september 2009 opdateret af: National Institute on Aging (NIA)
The main goal of this project is to use imaging and biomarkers to identify cognitively normal elderly people who are at increased risk for developing mild cognitive impairment (MCI). MCI is the earliest clinically detectable evidence for brain changes due to Alzheimer's disease (AD). The second goal of this project is to describe the inter-relationships among anatomical biomarkers, cerebrospinal fluid biomarkers, and cognition measures in those elderly people who develop MCI.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

The goal of this project is to use magnetic resonance imaging (MRI) and cerebrospinal fluid (CSF) biomarkers to identify cognitively normal participants who show the earliest clinically detectable brain changes of Alzheimer's disease (AD).

The major hypothesis for this study is that CSF P-tau231 measurement improves the accuracy of MRI and cerebrospinal fluid (CSF) measurements in predicting mild cognitive impairment (MCI). Validation of this hypothesis can lead to improved diagnostic tools for detecting AD as early as possible.

This 5-year longitudinal study will involve a baseline exam and two 18-month followup exams. Participants will undergo MRI scans, CSF collection and blood samples, neuropsychological performance testing, and medical, neurological and psychiatric assessment. The screening and diagnostic evaluations will be carried out by the New York University Alzheimer Disease Core Center (ADCC) and the NYU Center for Brain Health.

This study will enroll a minimum of 80 cognitively normal participants, 60 to 80 years of age, with English as their first language, with about 12 years of formal education, and who are living in the metropolitan New York City area. All participants will receive baseline and follow-up evaluations to rule out confounding medical, neurological, and psychiatric conditions that could affect cognition. The study coordinator will maintain 6-month telephone contact with all participants and their caregivers who are part of the project.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

80

Kontakter og lokationer

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

Studiesteder

    • New York
      • New York, New York, Forenede Stater, 10016
        • Rekruttering
        • Center for Brain Health, Silberstein Institute, New York University School of Medicine
        • Kontakt:
        • Ledende efterforsker:
          • Mony J. de Leon, Ed.D.

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

60 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Individuals of either sex, with a high school education, and between the ages of 60 and 80 years living in the New York City metropolitan area.
  • Minimum of 12 years education.
  • Participants will be classified as within normal limits on medical, psychiatric and neuropsychological examinations (performance that is better than -1.5 sd of the NYU norm based WMS-R delayed memory index).
  • Participants will have a global deterioration scale (GDS)=1 or 2. Those enrolled in the High-Risk group will have a GDS=2 and have a score of >25 on the Memory Complaint Questionnaire (MCQ). In high risk memory loss cases, an informed family member or caregiver will be interviewed to confirm that the participant can perform specific tasks.

Exclusion Criteria:

  • Past history or MRI evidence of brain damage including significant trauma, stroke, hydrocephalus, lacunar infarcts, seizures, mental retardation or serious neurological disorder.
  • Significant history of alcoholism or drug abuse.
  • History of psychiatric illness (e.g., schizophrenia, mania, Post-Traumatic Stress Disorder [PTSD], or depression).
  • Any focal neurological signs or significant neuropathology.
  • A score of 4 or greater on the Modified Hachinski Ischemia Scale, indicative of cerebrovascular disease.
  • A total score of 16 or more on the Hamilton Depression Scale to exclude possible cases of primary depression.
  • Evidence of clinically relevant and uncontrolled hypertensive, cardiac, pulmonary, vascular, metabolic or hematologic conditions.
  • Physical impairment of such severity as to adversely affect the validity of psychological testing.
  • Hostility or refusal to cooperate.
  • Any prosthetic devices (e.g., pacemaker or surgical clips) that could be affected by the magnetic field employed during MRI imaging.
  • History of familial early onset dementia.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tidsperspektiver: Fremadrettet

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Mony J. de Leon, Ed.D., Center for Brain Health, Silberstein Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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

1. april 2003

Studieafslutning

1. marts 2008

Datoer for studieregistrering

Først indsendt

28. oktober 2004

Først indsendt, der opfyldte QC-kriterier

28. oktober 2004

Først opslået (Skøn)

29. oktober 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. september 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2009

Sidst verificeret

1. september 2009

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner