NCT02330510Befejeződött
Amyloid and Glucose PET Imaging in Alzheimer and Vascular Cognitive Impairment Patients With Significant White Matter Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. dec. 16.
Rövid összefoglaló (regiszter, angolul)
The prevalence of both Alzheimer's Disease (AD) and stroke doubles each decade over 65 years old. Both are major causes of dementia, currently estimated to affect 46 million people worldwide. The current costs globally are $818 billion. Additionally, in population studies elders over 65 years, "covert" cerebral small vessel disease appears on MRI scans as silent lacunar infarcts in 25% as Microbleeds in 10%, and as focal or diffuse 'incidental' white matter disease (WMD) in 95%. WMD is extensive in 20%, with a clinical threshold effect around 10cc2. Small vessel disease is even more common in dementia, often coexisting with AD and independently contributing to cognitive decline and progression to dementia. Longitudinal imaging using cerebral amyloid labeling opens a new opportunity to understand the additive/interactive effects of small vessel disease and AD. The design of this study includes recruitment of two cohorts, including Mild Cognitive Impairment (MCI) and/or early Alzheimer Disease subjects from memory clinics and subjects with strokes/TIA from stroke prevention clinics. Inclusion criteria include the presence of moderate/extensive white matter disease, eg. Fazekas score of 2 (with confluent peri-ventricular hyperintensities) or Fazekas score of 3, as determined by previous MR or CT, > 60 years of age, Mini-Mental Status Exam (MMSE) scores ≥ 20. Subjects will undergo 3T structural MRI (including T1, PD/T2, FLAIR, GRE, DTI, ASL, and resting state fMRI), glucose PET, amyloid PET (using AV-45 florbetapir) and neuropsychological testing, as well as blood sampling. Repeat MR and PET/CT imaging and neuropsychological testing will be conducted at 24 months. The follow up assessments can also be completed at either year 1 or year 3 or Year 4 depending on the availability of study participants. The imaging portion is designed to closely parallel the Alzheimer's Disease Neuroimaging Initiative (ADNI) in order to benefit from the availability of both cognitively normal controls (NC), MCI and Alzheimer's disease subjects with minimal WMD.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 80 (tényleges)
- Első benyújtás
- 2014. jún. 27.
- Kezdés
- 2014. aug.
- Elsődleges befejezés
- 2024. dec. 10.
- Fő szponzor
- Dr. Sandra E Black
- Betegségek
- Alzheimer-kór
- NCT-szám
- NCT02330510
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 80
- 2014. aug. és az elsődleges befejezés (2024. dec. 10.) között
- 8 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Patients that have received radiation therapy to the head or neck or have been in another research study involving radiation
Más betegség
- Patients with persisting hemiparesis after a motor stroke, leg strength <4/5 on the Medical Research Council (MRC) scale; significant cerebellar ataxia
- Patients with major psychiatric disorder during the preceding 5 years
- History of substance abuse within the past 2 years
- Serious/chronic systemic or neurological illness (other than AD) such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities
- Pain or sleep disorder that could interfere with testing
Egyéb
- Subject meeting any one of the following criteria are not eligible for the the study:
- Patients with cortical or non-lacunar infarct on imaging
- Patients with contraindications to 3T MRI
- Claustrophobia
- Patients who are unable or unwilling to comply with protocol requirements or deemed by the investigator to be unfit for the study.
A regiszterben nem jelölt feltételek
- Eligible subjects must meet the following criteria before they are enrolled into the study:
- Patients with early AD or amnestic, non-amnestic single or multi-domain MCI who have confluent pvWMH; recruited from memory clinics. Or Patients who have had a minor stroke (e.g. subcortical lacunar infarct ≤1.5cm) or a TIA with confluent pvWMH; recruited from stroke prevention clinics.
- Age ≥ 60
- Patients who have provided written informed consent
- Patients with greater than 8 years of education
- Patients with an expected survival of greater than 2 years
- Patients that are sufficient fluency in French or English for cognitive testing
- Patients with a Mini-Mental State Exam score of (MMSE) ≥ 20
- Patients with pvWMH score on CT or MRI of ≥2 on the periventricular Fazekas scale 31 NOTE: Fazekas 2 patients can be included if they have bilateral posterior or anterior periventricular caps extending only 10mm from the ventricle (i.e. halfway into the surrounding white matter vs extending out to most of the surrounding white matter required for Fazekas 3)
Életkor a regiszterben: 60 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (8)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Alberta Health Services | Calgary | Kanada | Ismeretlen állapot |
| Hamilton General Hospital | Hamilton | Kanada | Ismeretlen állapot |
| Parkwood Hospital St. Joseph's Health Care | London | Kanada | Ismeretlen állapot |
| Jewish General Hospital | Montreal | Kanada | Ismeretlen állapot |
| CHU de Sherbrooke | Québec | Kanada | Ismeretlen állapot |
| CHU de Quebec | Québec | Kanada | Ismeretlen állapot |
| Sunnybrook Health Sciences Centre | Toronto | Kanada | Ismeretlen állapot |
| University of British Columbia Hospital | Vancouver | Kanada | Ismeretlen állapot |
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