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Molecular Cerebral Imaging in Incipient Dementia (MCI-ID) II

10 oktober 2018 bijgewerkt door: Daniel H. Silverman, University of California, Los Angeles

Early and Long-Term Health Outcomes of Molecular Cerebral Imaging in Incipient Dementia (MCI-ID) II

A substantial portion of people covered by Medicare will develop Alzheimer's disease and other forms of dementia that together devastate the lives of millions of people in the United States, and cost us a total of over $200 billion every year. Getting a brain scan with a PET scanner to look for abnormal brain metabolism patterns is recognized as "reasonable and necessary" for some patients with "a recently established diagnosis of dementia" (Centers for Medicare and Medicaid Services (CMS), Decision Memo CAG-00088R), but the evidence is considered less clear for patients having less severe cognitive problems, and/or for patients getting a brain scan with a PET scanner to look for abnormal proteins in the brain (CMS Decision Memo CAG-00431N). This project employs a scientifically rigorous design (prospective, multi-centered, randomized controlled trial) to determine whether such PET scanning can help distinguish more accurately than is being done in current clinical practice those patients with early molecular changes in their brains who will benefit from Alzheimer related treatments from those patients who will not, as proven by measuring to what extent the PET scans actually lead to earlier appropriate therapy, and in fact result in improved outcomes for Medicare beneficiaries and for the health care system in which they obtain care.

Studie Overzicht

Toestand

Ingetrokken

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The overarching objective of this project is to test whether diagnostic assessments informed by data on molecular cerebral changes can lead to improved health outcomes of an epidemiologically major segment of the geriatric patient population - people experiencing changes in their cognitive skills relative to their prior level of cerebral functioning. In the present proposal, we specifically aim to measure how knowledge of molecular cerebral information 1) influences the therapeutic management of patients being evaluated for symptoms of cognitive decline, and 2) impacts upon long-term health outcomes, particularly for patients having findings on positron emission tomography (PET) scans consistent with presence of Alzheimer's disease (AD)- like changes in their brains. Patients suffering from documentable decline of cognitive function will undergo baseline neuropsychologic testing, and neuroimaging with MRI and PET. Reports of PET scans will be sealed at the time of interpretation, and then randomized with respect to whether they are released to the patients' managing physicians at the time of interpretation, or two years after the time that scanning is performed. All treatment decisions will be made by the managing physicians and their patients. Cognitive abilities, functional status, and other clinical and social history parameters will be assessed every six months. Our central hypothesis is that among the group of patients whose PET scan results are conveyed to their physicians at the time of scanning, cognitive and functional abilities will be maintained at a higher level during the two years following PET. Beyond addressing the specific aims noted above and further described below, a valuable feature of this project will be the collection of a rich source of data that can be used to address many questions beyond its major focus (e.g., diagnostic value of volumetric MRI data used instead of, or in conjunction with, PET data in the Medicare beneficiary population; incremental value of applying statistically parameterizing and/or quantifying software tools to PET data). The protocol has been designed to conform to all standards specified by the Centers for Medicare and Medicaid Services (CMS) for Coverage with Evidence Development (CED), generally, and with all requirements for a CED study responsive to CMS Decision Memo CAG-00431N, specifically.

Studietype

Ingrijpend

Fase

  • Fase 3

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Cognitive decline and/or personality change is present, as observable by physician and/or close contact(s) of the patient; or in the absence of this, the patient provides a clear history of decline that the patient's physician deems to be reliable.
  2. If history or neurologic exam reveals findings suspicious for stroke, tumor, bleed, ictal activity, or hydrocephalus, then CT/MRI and appropriate neurological or neurosurgical consultation must have been obtained.
  3. Standard history, physical, and laboratory screen have been performed to identify possible presence of depression, substance abuse, malnourishment, medication effects and interactions, cardiopulmonary compromise, electrolyte/calcium imbalance, anemia, hypoxemia, infection, thyroid dysfunction, renal dysfunction, hepatic dysfunction, or glucose dysregulation.
  4. Any positive findings revealed in 2) or 3) above have been appropriately treated, wherever possible, but cognitive/behavioral deficit persists post-therapy.

Exclusion Criteria:

  1. Subjects under age 65 will not be recruited, in order to enhance the relevance of the project by focusing on the group of Medicare beneficiaries in whom serious concerns about early signs and symptoms of senile onset dementia are most typically emerging.
  2. Cognitive dysfunction has impaired subject's ability to perform activities of daily living.
  3. Present or past history of thyroid disease.
  4. Claustrophobia or metal in body or other condition that would preclude PET or MRI from being acquired.
  5. Visual, auditory or motor deficits that would preclude accurate neuropsychological testing.
  6. AD-specific pharmacotherapy already initiated.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: prompt amyloid imaging, delayed FDG-PET
Subject's managing physicians will be given the results of amyloid imaging scans immediately. FDG-PET results will be released two years after scanning.
Procedure: Amyloid imaging
Amyloid imaging brain scans are administered once to all arms.
Procedure: FDG-PET
[F-18] FDG-PET brain scans are administered once to all arms.
Experimenteel: prompt FDG-PET, delayed amyloid imaging
Subject's managing physicians will be given the results of FDG-PET scans immediately. Amyloid imaging results will be released two years after scanning.
Procedure: Amyloid imaging
Amyloid imaging brain scans are administered once to all arms.
Procedure: FDG-PET
[F-18] FDG-PET brain scans are administered once to all arms.
Experimenteel: prompt FDG-PET, prompt amyloid imaging
Both FDG-PET and amyloid imaging scan results will be made immediately available to the managing physician.
Procedure: Amyloid imaging
Amyloid imaging brain scans are administered once to all arms.
Procedure: FDG-PET
[F-18] FDG-PET brain scans are administered once to all arms.
Actieve vergelijker: delayed FDG-PET, delayed amyloid imaging
Neither FDG-PET nor amyloid imaging scan results will be released to the managing physician for 2 years.
Procedure: Amyloid imaging
Amyloid imaging brain scans are administered once to all arms.
Procedure: FDG-PET
[F-18] FDG-PET brain scans are administered once to all arms.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of change from baseline in neuropsychological (cognitive,functional) test results
Tijdsspanne: baseline, 6 months, 12 months, 18 months, 24 months
Study participants will undergo neuropsychological testing at baseline and every six months for two years.
baseline, 6 months, 12 months, 18 months, 24 months
Utilization of healthcare resources
Tijdsspanne: over 2 years
over 2 years
FDG-PET and amyloid imaging results, compared with working diagnoses made before and after time of imaging
Tijdsspanne: baseline and up to 2 years
Study participants will undergo FDG-PET and amyloid imaging. Working diagnoses made before and after the imaging is performed will be compared.
baseline and up to 2 years
Rates of prescription of AD-specific therapies
Tijdsspanne: baseline, 6 months, 12 months, 18 months, 24 months
Comparisons between the rate of prescription for AD-specific therapies and release type (either immediate or delayed release) will be made.
baseline, 6 months, 12 months, 18 months, 24 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, Los Angeles

Medewerkers

Centers for Medicare and Medicaid Services

Onderzoekers

  • Hoofdonderzoeker: Daniel Silverman, MD, Ph.D., University of California, Los Angeles

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

1 juni 2018

Primaire voltooiing (Verwacht)

1 oktober 2022

Studie voltooiing (Verwacht)

1 december 2022

Studieregistratiedata

Eerst ingediend

9 december 2014

Eerst ingediend dat voldeed aan de QC-criteria

10 december 2014

Eerst geplaatst (Schatting)

15 december 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 oktober 2018

Laatste update ingediend die voldeed aan QC-criteria

10 oktober 2018

Laatst geverifieerd

1 oktober 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 11-00815-02

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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Klinische onderzoeken op Amyloid imaging

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