- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00966017
Glucose Metabolic, Amyloid, and Tau Brain Imaging in Down Syndrome and Dementia
23. december 2009 opdateret af: National Institute on Aging (NIA)
The purpose of this study is to develop small molecule radio-labeled probes of beta-amyloid, to be used with positron emission tomography (PET) for early detection and treatment monitoring of Alzheimer disease (AD).
The study hypothesis is that PET imaging of small molecule probes, in the form of novel fluorescent dyes with radioactive labels, will demonstrate cerebral patterns in patients with AD that are distinct from those of age-matched persons who are cognitively intact.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
This is a naturalistic study in which clinical evaluations and brain scans will be performed on 72 people with Down syndrome (DS), 36 non-demented and 36 with dementia, as well as 36 age-matched healthy controls.
Participants will receive comprehensive clinical and neuropsychological assessments.
PET and MRI scans will be performed at baseline and after two years of follow up.
All participants will have blood drawn for APOE genotyping during their baseline evaluations.
The intellectual range of participants with DS will be restricted to IQ scores of 45 to 60 (moderate range) to reduce variability, particularly due to extreme low levels of intellectual ability.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
108
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Los Angeles, California, Forenede Stater, 90024
- Rekruttering
- UCLA
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Ledende efterforsker:
- Gary W. Small, MD
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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
45 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Individuals will be identified and recruited using IRB approved flyers distributed to treating clinicians, caregivers from Board and Care homes, sheltered workshop administrators (where potential participants are employed), and representatives of County Regional Centers (primary evaluation and treatment centers for developmentally delayed individuals).
Beskrivelse
Inclusion Criteria:
- Age 45 years or older
- No significant cerebrovascular disease - modified Ischemic Score of < 4
- Adequate visual and auditory acuity to allow neuropsychological testing
- Screening laboratory tests and ECG without significant abnormalities that might interfere with the study
Additional Inclusion Criteria for Controls
- MMSE score between 24 and 30 (unless < 8 years of educational achievement)
- The following medications are allowed if stable for > 1 month: antidepressants (without anticholinergic effects) if not currently depressed and no history of major depression for 2 years; estrogen replacement therapy; thyroid replacement therapy as long as individual is euthyroid; antihypertensives that do not influence cognitive function
Additional Inclusion Criteria for Individuals with Down syndrome
- Family member or caregiver available; caregiver relationship 2 years or longer
- Karyotype DX of trisomy or translocation DS Mosaic form of Down syndrome
- English-speaking
Exclusion Criteria:
- Evidence of neurological or other physical illness that could produce cognitive deterioration; volunteers with a history of TIAs, carotid bruits, or lacunes on MRI scan will be excluded
- Parkinson's Disease
- History of myocardial infarction within the previous year or unstable cardiac disease
- Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100), history of significant liver disease, clinically significant pulmonary disease, diabetes, or cancer
- Major psychiatric disorders, such as bipolar disorder or schizophrenia
- Medicines that could influence psychometric test results
- Use of any of the following drugs: centrally active beta-blockers, narcotics, clonidine, anti-Parkinsonian medications, benzodiazepines, systemic corticosteroids, medications with significant cholinergic or anticholinergic effects, anti-convulsants, or warfarin
- Current diagnosis or history of alcoholism or drug dependence
- Evidence of untreated depression or untreated anxiety
- Use of any investigational drugs within the previous month or longer, depending on drug half-life
- Contraindication for MRI scan (e.g., metal in body, claustrophobia)
- Diagnosis of possible or probable AD or any other dementia (e.g., vascular, Lewy body, frontotemporal) or MCI
Additional Exclusion Criteria for Individuals with Down syndrome
- Mosaic form of Down syndrome
- History of clinically significant neurological disorder or disease and Psychiatric diagnosis or treatment within 3 months prior to screening
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
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DS
Dem med Downs syndrom
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Ikke-DS
Sund kontrol
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Gary W. Small, MD, Semel Institute for Neuroscience & Human Behavior, David Geffen School of Medicine at UCLA
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.
Generelle publikationer
- Small GW, Kepe V, Ercoli LM, Siddarth P, Bookheimer SY, Miller KJ, Lavretsky H, Burggren AC, Cole GM, Vinters HV, Thompson PM, Huang SC, Satyamurthy N, Phelps ME, Barrio JR. PET of brain amyloid and tau in mild cognitive impairment. N Engl J Med. 2006 Dec 21;355(25):2652-63. doi: 10.1056/NEJMoa054625.
- Nelson LD, Scheibel KE, Ringman JM, Sayre JW. An experimental approach to detecting dementia in Down syndrome: a paradigm for Alzheimer's disease. Brain Cogn. 2007 Jun;64(1):92-103. doi: 10.1016/j.bandc.2007.01.003. Epub 2007 Mar 26.
- Nelson LD, Orme D, Osann K, Lott IT. Neurological changes and emotional functioning in adults with Down Syndrome. J Intellect Disabil Res. 2001 Oct;45(Pt 5):450-6. doi: 10.1046/j.1365-2788.2001.00379.x.
- Small GW, Siddarth P, Burggren AC, Kepe V, Ercoli LM, Miller KJ, Lavretsky H, Thompson PM, Cole GM, Huang SC, Phelps ME, Bookheimer SY, Barrio JR. Influence of cognitive status, age, and APOE-4 genetic risk on brain FDDNP positron-emission tomography imaging in persons without dementia. Arch Gen Psychiatry. 2009 Jan;66(1):81-7. doi: 10.1001/archgenpsychiatry.2008.516.
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. juli 2009
Primær færdiggørelse (Forventet)
1. februar 2014
Studieafslutning (Forventet)
1. februar 2014
Datoer for studieregistrering
Først indsendt
24. august 2009
Først indsendt, der opfyldte QC-kriterier
24. august 2009
Først opslået (Skøn)
26. august 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. december 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. december 2009
Sidst verificeret
1. december 2009
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Patologiske processer
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neurologiske manifestationer
- Neuroadfærdsmæssige manifestationer
- Neurokognitive lidelser
- Sygdom
- Medfødte abnormiteter
- Genetiske sygdomme, medfødte
- Neurodegenerative sygdomme
- Intellektuel handicap
- Tauopatier
- Abnormiteter, multiple
- Kromosomlidelser
- Syndrom
- Demens
- Alzheimers sygdom
- Downs syndrom
Andre undersøgelses-id-numre
- IA0167
- 1R01AG033015-01 (U.S. NIH-bevilling/kontrakt)
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 .
Kliniske forsøg med Downs syndrom
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Centre National d'Etudes SpatialesEuropean Space Agency; MEDES - IMPSAfsluttetVægtløshed | Simuleret mikrotyngdekraft af Head Down Tilt SengelænFrankrig
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Superior UniversityAktiv, ikke rekrutterende
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Assiut UniversityIkke rekrutterer endnuKromosomale abnormiteter | Translocation Down Syndrome
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Zealand University HospitalRigshospitalet, Denmark; Herlev HospitalUkendtNeoadjuverende terapi | Lokalt avanceret endetarmskræft | Elektrokemoterapi | Down StagingDanmark
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GlaxoSmithKlineIkke rekrutterer endnu
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Unravel Biosciences, Inc.RekrutteringPitt Hopkins syndromColombia
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Helen Keller Eye Research FoundationFive Lakes Clinical Research Consulting, LLCRekrutteringStickler syndrom type 2 | Stickler syndrom type 1Forenede Stater
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University of California, Los AngelesBoston Children's Hospital; Duke University; Children's Hospital Medical...RekrutteringBohring-Opitz syndrom | ASXL1 genmutation | Shashi-Pena syndrom | ASXL2-genmutation | Bainbridge-Ropers syndrom | ASXL3 genmutationForenede Stater
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Neuren Pharmaceuticals LimitedRekrutteringPhelan-McDermid syndromForenede Stater, Canada