Alzheimer's DiseaseMITNEC C6NCT02330510
Amyloid and Glucose PET Imaging in Alzheimer and Vascular Cognitive Impairment Patients With Significant White Matter Disease
An observational study of Alzheimer's Disease and Small Vessel Disease White Matter Hyperintensities Subtype, run by Dr. Sandra E Black at 8 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease, Small Vessel Disease White Matter Hyperintensities Subtype, Vascular Cognitive Impairment
- How many people
- 80 participants
- Where
- 8 sitesCanada
- Study dates
- Aug 2014to 10 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two groups of patients will participate in this study: 1. Patients with early Alzheimer's Disease (AD) or amnestic or multi-domain Mild Cognitive Impairment who have extensive pvWMH; recruited from memory clinics (n= 40) 2. Patients who have had a stroke or a Transient Ischemic Attack (TIA) with extensive pvWMH; recruited from stroke prevention clinics (n= 40)
Who may be able to join
None listed.
Who cannot join
- 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 persisting hemiparesis after a motor stroke, leg strength <4/5 on the Medical Research Council (MRC) scale; significant cerebellar ataxia
- Patients with contraindications to 3T MRI
- Patients with major psychiatric disorder during the preceding 5 years
- History of substance abuse within the past 2 years
Show all 11Show fewer
- 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
- Claustrophobia
- Patients that have received radiation therapy to the head or neck or have been in another research study involving radiation
- Patients who are unable or unwilling to comply with protocol requirements or deemed by the investigator to be unfit for the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
University of Alberta Health Services
Calgary, Alberta
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Parkwood Hospital St. Joseph's Health Care
London, Ontario, N6C 5J1
Jewish General Hospital
Montreal, Quebec, H3T 1E2
CHU de Sherbrooke
Québec, Quebec, J1H 5H3
CHU de Quebec
Québec, Quebec
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University of British Columbia Hospital
Vancouver, British Columbia, V6T 2B5
About this study
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.
Read the detailed description
This study will be a multi-center trial to be conducted in centers across Canada and approximately 80 patients will be enrolled. Participants will be recruited from both stroke prevention (N=40) and memory clinics (N=40). For comparison, we will access the publically-available data using a very similar protocol being collected from normal controls (N=250), MCI (N=250 early MCI, N=150 late MCI) and AD patients (N=150) without significant white matter disease, who are participating in the Alzheimer's Disease Neuroimaging Initiative (ADNI-GO and ADNI 2, N=800), to choose representative samples for comparison to those with scores ≤ 1 who represent the non-white matter disease group.
Three imaging modalities will be used with each participant. 3 Telsa MRI scans will be acquired, using an ADNI based protocol, except for the addition of a PD/T2 interleved sequence. Participants will also undergo 18-fluoro PET with the AVID-45 ligand and 18-fluorodeoxyglucose PET using the ADNI protocols.
The primary objectives are to characterize at baseline and 2-year follow-up in patients with significant Periventricular White Matter Hyperintensities (pvWMH), presenting as transient cerebrovascular events or memory problems, patterns of: 1. Uptake of amyloid on Florbetapir F-18 PET/CT 2. Glucose uptake on 18F-FDG PET/CT 3. Volumetric measures of brain structure on MRI imaging 4. Performance on standard neuropsychological assessments, activities of daily living and gait speed.
Secondary objectives are to: 1. Compare the relationship between amyloid brain uptake, pvWMH volumes, and cognitive scores in patients with significant pvWMH and a control group of individuals that are cognitively normal, MCI or AD, with mild pvWMH, identified from the ADNI database. 2. Examine the relationship between amyloid uptake, ApoE e4 genotype, and structural MRI volumes in patients with a high burden of pvWMH. 3. Evaluate the utility of baseline brain amyloid to predict cognitive decline and increases in pvWMH volume at 2 years follow up. 4. Evaluate the safety of a single intravenous dose of Florbetapir F 18 Injection (370 MBq +/- 10%) in subjects with significant pvWMH.
- Conditions
- Alzheimer's Disease, Small Vessel Disease White Matter Hyperintensities Subtype, Vascular Cognitive Impairment
- Keywords
- Alzheimer's Disease, White Matter Hyperintensities, Vascular Cognitive Impairment, Amyloid Imaging, Transient Ischemic Attack
- Medical subject headings
- Alzheimer Disease, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's Disease | Individuals with early Alzheimer's Disease (AD) or amnestic or multi-domain Mild Cognitive Impairment who have extensive Periventricular White Matter Hyperintensities | |
| Transient Ischemic Attack/Mild Subcortical Stroke | Individuals who have had a mild subcortical stroke or a Transient Ischemic Attack (TIA) with extensive Periventricular White Matter Hyperintensities in the absence of cortical infarcts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in F18 florbetapir SUVR over 2 years in patients with moderate-severe White Matter Hyperintensities, at baseline and 1 year follow-up brain uptake of Florbetapir F 18
Standardized measures of F18 florbetapir brain uptake will be compared to baseline uptake patterns and prevalence of signal uptake in various areas
Measured: 24 months
Secondary outcomes (6)
Florbetapir F18 SUVR brain uptake, regional FDG metabolic measures and regional volutmetrics on MRI based volume including grey and white matter, small vessel disease, as well as regional cortical thickness measures.
Standardized measures of F18 florbetapir brain uptake will be correlated with posterior-cingulate and parietal-temporal metabolism. We will also correlate with hippocampal, ventricular and regional volumes and with cortical thickness, derived with Lesion Explorer enhancement
Measured: 24 months
F18 florbetapir SUVR brain uptake, with Periventricular White Matter Hyperintensity volumes and cognitive scores.
The relationship between F18 florbetapir brain uptake, Periventricular White Matter Hyperintensity volumes, executive function and memory scores, in patients with significant pvWMH, accounting for relevant co-variates (age, education), using multivariate analysis including Partial Least Squares (PLS).
Measured: 24 months
F18 florbetapir brain SUVR uptake, Periventricular White Matter Hyperintensity volumes and cognitive scores in an age-matched group of normal controls, MCI and AD subjects with minimal or mild degrees of pvWMH.
Mutlivariate analysis will be used to carry out this analysis, including PLS
Measured: 24 months
F18 florbetapir SUVR brain uptake, ApoE e4 genotype status, and White Matter Hyperintensity volumes in patients with a high burden of pvWMH.
Measured: 24 months
Baseline F18 florbetapir SUVR brain uptake, cognitive score decline and increase in White Matter Hyperintensity volume at 2 year follow up.
Measured: 24 months
Assess any adverse events or serious adverse events occurring with a a single intravenous dose of F18 florbetapir Injection (370 MBq +/- 10%) in subjects with significant pvWM
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startAug 2014
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Sandra E Black
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Sandra E Black, Sunnybrook Health Sciences Centre
- Investigators
- Sandra E. Black, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330510
- Sponsor's protocol ID
- Ml1-112246
- Acronym
- MITNEC C6
- Status last verified
- Dec 2024
- First submitted
- 27 Jun 2014
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xhima K, Ottoy J, Gibson E, Zukotynski K, Scott C, Feliciano GJ, Adamo S, Kuo PH, Borrie MJ, Chertkow H, Frayne R, Laforce R Jr, Noseworthy MD, Prato FS, Sahlas DJ, Smith EE, Sossi V, Thiel A, Soucy JP, Tardif JC, Goubran M, Black SE, Ramirez J; Medical Imaging Trials Network of Canada (MITNEC). Distinct spatial contributions of amyloid pathology and cerebral small vessel disease to hippocampal morphology. Alzheimers Dement. 2024 May;20(5):3687-3695. doi: 10.1002/alz.13791. Epub 2024 Apr 4.
PubMed 38574400Boone L, Biparva M, Mojiri Forooshani P, Ramirez J, Masellis M, Bartha R, Symons S, Strother S, Black SE, Heyn C, Martel AL, Swartz RH, Goubran M. ROOD-MRI: Benchmarking the robustness of deep learning segmentation models to out-of-distribution and corrupted data in MRI. Neuroimage. 2023 Sep;278:120289. doi: 10.1016/j.neuroimage.2023.120289. Epub 2023 Jul 24.
PubMed 37495197Ottoy J, Ozzoude M, Zukotynski K, Kang MS, Adamo S, Scott C, Ramirez J, Swardfager W, Lam B, Bhan A, Mojiri P, Kiss A, Strother S, Bocti C, Borrie M, Chertkow H, Frayne R, Hsiung R, Laforce RJ, Noseworthy MD, Prato FS, Sahlas DJ, Smith EE, Kuo PH, Chad JA, Pasternak O, Sossi V, Thiel A, Soucy JP, Tardif JC, Black SE, Goubran M; Medical Imaging Trials Network of Canada (MITNEC) and Alzheimer's Disease Neuroimaging Initiative (ADNI). Amyloid-PET of the white matter: Relationship to free water, fiber integrity, and cognition in patients with dementia and small vessel disease. J Cereb Blood Flow Metab. 2023 Jun;43(6):921-936. doi: 10.1177/0271678X231152001. Epub 2023 Jan 25.
PubMed 36695071Ottoy J, Ozzoude M, Zukotynski K, Adamo S, Scott C, Gaudet V, Ramirez J, Swardfager W, Cogo-Moreira H, Lam B, Bhan A, Mojiri P, Kang MS, Rabin JS, Kiss A, Strother S, Bocti C, Borrie M, Chertkow H, Frayne R, Hsiung R, Laforce RJ, Noseworthy MD, Prato FS, Sahlas DJ, Smith EE, Kuo PH, Sossi V, Thiel A, Soucy JP, Tardif JC, Black SE, Goubran M; Medical Imaging Trial Network of Canada (MITNEC) and Alzheimer's Disease Neuroimaging Initiative (ADNI). Vascular burden and cognition: Mediating roles of neurodegeneration and amyloid PET. Alzheimers Dement. 2023 Apr;19(4):1503-1517. doi: 10.1002/alz.12750. Epub 2022 Sep 1.
PubMed 36047604Mojiri Forooshani P, Biparva M, Ntiri EE, Ramirez J, Boone L, Holmes MF, Adamo S, Gao F, Ozzoude M, Scott CJM, Dowlatshahi D, Lawrence-Dewar JM, Kwan D, Lang AE, Marcotte K, Leonard C, Rochon E, Heyn C, Bartha R, Strother S, Tardif JC, Symons S, Masellis M, Swartz RH, Moody A, Black SE, Goubran M. Deep Bayesian networks for uncertainty estimation and adversarial resistance of white matter hyperintensity segmentation. Hum Brain Mapp. 2022 May;43(7):2089-2108. doi: 10.1002/hbm.25784. Epub 2022 Jan 28.
PubMed 35088930Ntiri EE, Holmes MF, Forooshani PM, Ramirez J, Gao F, Ozzoude M, Adamo S, Scott CJM, Dowlatshahi D, Lawrence-Dewar JM, Kwan D, Lang AE, Symons S, Bartha R, Strother S, Tardif JC, Masellis M, Swartz RH, Moody A, Black SE, Goubran M. Improved Segmentation of the Intracranial and Ventricular Volumes in Populations with Cerebrovascular Lesions and Atrophy Using 3D CNNs. Neuroinformatics. 2021 Oct;19(4):597-618. doi: 10.1007/s12021-021-09510-1. Epub 2021 Feb 1.
PubMed 33527307
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amyloid and Glucose PET Imaging in Alzheimer and Vascular Cognitive Impairment Patients With Significant White Matter Disease
- ClinicalTrials.gov ID
- NCT02330510
- Acronym / sponsor ID
- MITNEC C6 / Ml1-112246
- Conditions
- Alzheimer's Disease, Small Vessel Disease White Matter Hyperintensities Subtype, Vascular Cognitive Impairment
- Keywords
- Alzheimer's Disease, White Matter Hyperintensities, Vascular Cognitive Impairment, Amyloid Imaging, Transient Ischemic Attack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dr. Sandra E BlackUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 5 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a multi-center trial to be conducted in centers across Canada and approximately 80 patients will be enrolled. Participants will be recruited from both stroke prevention (N=40) and memory clinics (N=40). For comparison, we will access the publically-available data using a very similar protocol being collected from normal controls (N=250), MCI (N=250 early MCI, N=150 late MCI) and AD patients (N=150) without significant white matter disease, who are participating in the Alzheimer's Disease Neuroimaging Initiative (ADNI-GO and ADNI 2, N=800), to choose representative samples for comparison to those with scores ≤ 1 who represent the non-white matter disease group.
Three imaging modalities will be used with each participant. 3 Telsa MRI scans will be acquired, using an ADNI based protocol, except for the addition of a PD/T2 interleved sequence. Participants will also undergo 18-fluoro PET with the AVID-45 ligand and 18-fluorodeoxyglucose PET using the ADNI protocols.
The primary objectives are to characterize at baseline and 2-year follow-up in patients with significant Periventricular White Matter Hyperintensities (pvWMH), presenting as transient cerebrovascular events or memory problems, patterns of: 1. Uptake of amyloid on Florbetapir F-18 PET/CT 2. Glucose uptake on 18F-FDG PET/CT 3. Volumetric measures of brain structure on MRI imaging 4. Performance on standard neuropsychological assessments, activities of daily living and gait speed.
Secondary objectives are to: 1. Compare the relationship between amyloid brain uptake, pvWMH volumes, and cognitive scores in patients with significant pvWMH and a control group of individuals that are cognitively normal, MCI or AD, with mild pvWMH, identified from the ADNI database. 2. Examine the relationship between amyloid uptake, ApoE e4 genotype, and structural MRI volumes in patients with a high burden of pvWMH. 3. Evaluate the utility of baseline brain amyloid to predict cognitive decline and increases in pvWMH volume at 2 years follow up. 4. Evaluate the safety of a single intravenous dose of Florbetapir F 18 Injection (370 MBq +/- 10%) in subjects with significant pvWMH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease | – | –Individuals with early Alzheimer's Disease (AD) or amnestic or multi-domain Mild Cognitive Impairment who have extensive Periventricular White Matter Hyperintensities |
| Transient Ischemic Attack/Mild Subcortical Stroke | – | –Individuals who have had a mild subcortical stroke or a Transient Ischemic Attack (TIA) with extensive Periventricular White Matter Hyperintensities in the absence of cortical infarcts |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two groups of patients will participate in this study: 1. Patients with early Alzheimer's Disease (AD) or amnestic or multi-domain Mild Cognitive Impairment who have extensive pvWMH; recruited from memory clinics (n= 40) 2. Patients who have had a stroke or a Transient Ischemic Attack (TIA) with extensive pvWMH; recruited from stroke prevention clinics (n= 40)
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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 persisting hemiparesis after a motor stroke, leg strength <4/5 on the Medical Research Council (MRC) scale; significant cerebellar ataxia
- Patients with contraindications to 3T MRI
- Patients with major psychiatric disorder during the preceding 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in F18 florbetapir SUVR over 2 years in patients with moderate-severe White Matter Hyperintensities, at baseline and 1 year follow-up brain uptake of Florbetapir F 18
Time frame: 24 months
Standardized measures of F18 florbetapir brain uptake will be compared to baseline uptake patterns and prevalence of signal uptake in various areas
6 secondary outcomes
Florbetapir F18 SUVR brain uptake, regional FDG metabolic measures and regional volutmetrics on MRI based volume including grey and white matter, small vessel disease, as well as regional cortical thickness measures.
Time frame: 24 months
F18 florbetapir SUVR brain uptake, with Periventricular White Matter Hyperintensity volumes and cognitive scores.
Time frame: 24 months
F18 florbetapir brain SUVR uptake, Periventricular White Matter Hyperintensity volumes and cognitive scores in an age-matched group of normal controls, MCI and AD subjects with minimal or mild degrees of pvWMH.
Time frame: 24 months
F18 florbetapir SUVR brain uptake, ApoE e4 genotype status, and White Matter Hyperintensity volumes in patients with a high burden of pvWMH.
Time frame: 24 months
Baseline F18 florbetapir SUVR brain uptake, cognitive score decline and increase in White Matter Hyperintensity volume at 2 year follow up.
Time frame: 24 months
Assess any adverse events or serious adverse events occurring with a a single intravenous dose of F18 florbetapir Injection (370 MBq +/- 10%) in subjects with significant pvWM
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 38574400Xhima K, Ottoy J, Gibson E, Zukotynski K, Scott C, Feliciano GJ, Adamo S, Kuo PH, Borrie MJ, Chertkow H, Frayne R, Laforce R Jr, Noseworthy MD, Prato FS, Sahlas DJ, Smith EE, Sossi V, Thiel A, Soucy JP, Tardif JC, Goubran M, Black SE, Ramirez J; Medical Imaging Trials Network of Canada (MITNEC). Distinct spatial contributions of amyloid pathology and cerebral small vessel disease to hippocampal morphology. Alzheimers Dement. 2024 May;20(5):3687-3695. doi: 10.1002/alz.13791. Epub 2024 Apr 4.
- Derived from this study: PubMed 37495197Boone L, Biparva M, Mojiri Forooshani P, Ramirez J, Masellis M, Bartha R, Symons S, Strother S, Black SE, Heyn C, Martel AL, Swartz RH, Goubran M. ROOD-MRI: Benchmarking the robustness of deep learning segmentation models to out-of-distribution and corrupted data in MRI. Neuroimage. 2023 Sep;278:120289. doi: 10.1016/j.neuroimage.2023.120289. Epub 2023 Jul 24.
- Derived from this study: PubMed 36695071Ottoy J, Ozzoude M, Zukotynski K, Kang MS, Adamo S, Scott C, Ramirez J, Swardfager W, Lam B, Bhan A, Mojiri P, Kiss A, Strother S, Bocti C, Borrie M, Chertkow H, Frayne R, Hsiung R, Laforce RJ, Noseworthy MD, Prato FS, Sahlas DJ, Smith EE, Kuo PH, Chad JA, Pasternak O, Sossi V, Thiel A, Soucy JP, Tardif JC, Black SE, Goubran M; Medical Imaging Trials Network of Canada (MITNEC) and Alzheimer's Disease Neuroimaging Initiative (ADNI). Amyloid-PET of the white matter: Relationship to free water, fiber integrity, and cognition in patients with dementia and small vessel disease. J Cereb Blood Flow Metab. 2023 Jun;43(6):921-936. doi: 10.1177/0271678X231152001. Epub 2023 Jan 25.
- Derived from this study: PubMed 36047604Ottoy J, Ozzoude M, Zukotynski K, Adamo S, Scott C, Gaudet V, Ramirez J, Swardfager W, Cogo-Moreira H, Lam B, Bhan A, Mojiri P, Kang MS, Rabin JS, Kiss A, Strother S, Bocti C, Borrie M, Chertkow H, Frayne R, Hsiung R, Laforce RJ, Noseworthy MD, Prato FS, Sahlas DJ, Smith EE, Kuo PH, Sossi V, Thiel A, Soucy JP, Tardif JC, Black SE, Goubran M; Medical Imaging Trial Network of Canada (MITNEC) and Alzheimer's Disease Neuroimaging Initiative (ADNI). Vascular burden and cognition: Mediating roles of neurodegeneration and amyloid PET. Alzheimers Dement. 2023 Apr;19(4):1503-1517. doi: 10.1002/alz.12750. Epub 2022 Sep 1.
- Derived from this study: PubMed 35088930Mojiri Forooshani P, Biparva M, Ntiri EE, Ramirez J, Boone L, Holmes MF, Adamo S, Gao F, Ozzoude M, Scott CJM, Dowlatshahi D, Lawrence-Dewar JM, Kwan D, Lang AE, Marcotte K, Leonard C, Rochon E, Heyn C, Bartha R, Strother S, Tardif JC, Symons S, Masellis M, Swartz RH, Moody A, Black SE, Goubran M. Deep Bayesian networks for uncertainty estimation and adversarial resistance of white matter hyperintensity segmentation. Hum Brain Mapp. 2022 May;43(7):2089-2108. doi: 10.1002/hbm.25784. Epub 2022 Jan 28.
- Derived from this study: PubMed 33527307Ntiri EE, Holmes MF, Forooshani PM, Ramirez J, Gao F, Ozzoude M, Adamo S, Scott CJM, Dowlatshahi D, Lawrence-Dewar JM, Kwan D, Lang AE, Symons S, Bartha R, Strother S, Tardif JC, Masellis M, Swartz RH, Moody A, Black SE, Goubran M. Improved Segmentation of the Intracranial and Ventricular Volumes in Populations with Cerebrovascular Lesions and Atrophy Using 3D CNNs. Neuroinformatics. 2021 Oct;19(4):597-618. doi: 10.1007/s12021-021-09510-1. Epub 2021 Feb 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra E. Black, MD principal investigator
Sunnybrook Health Sciences Centre
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Small Vessel Disease White Matter Hyperintensities Subtype, run by Dr. Sandra E Black at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in F18 florbetapir SUVR over 2 years in patients with moderate-severe White Matter Hyperintensities, at baseline and 1 year follow-up brain uptake of Florbetapir F 18 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02330510, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.