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Mild Cognitive Impairment (VCI) for Lewy Body Disease (BEAM Trial)

N/A
Recruiting
Led By Sandra Black, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one-time assessment
Awards & highlights

Summary

This trialundefined

Eligible Conditions
  • Lewy Body Disease
  • Alzheimer's Disease
  • Mild Cognitive Impairment
  • Vascular Cognitive Impairment
  • Parkinson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one-time assessment
This trial's timeline: 3 weeks for screening, Varies for treatment, and one-time assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amyloid Depostition
Retinal nerve fiber layer thickness
Secondary outcome measures
Retinal artery narrowing
Retinal venular widening

Side effects data

From 2016 Phase 2 trial • 89 Patients • NCT01607476
4%
Dizziness (mild)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alzheimer's Disease
Cognitive Normal Elderly
Cognitive Normal Young

Trial Design

5Treatment groups
Experimental Treatment
Group I: Subcortical Vascular Impairment (VCI)Experimental Treatment1 Intervention
Sixty-five subjects meeting the American Heart Association-American Stroke Association (AHA-ASA) criteria for probable vascular dementia (VaD) or probable vascular mild cognitive impairment (VaMCI) due to subcortical ischemic vascular disease , and probable or possible Cerebral Amyloid Angiopathy using the Modified Boston Criteria116 will be enrolled. All patients will undergo SD-OCT, eye tracking, gait and balance assessments, blood draw for genomics and fluid biomarkers, neuropsychological assessment, brain MRI and brain amyloid PET. A subset will undergo SV-OCT.
Group II: Normal ControlsExperimental Treatment1 Intervention
Upto 85 normal elders, 50-90 years old who are within normal limits on the study neuropsychological battery will be enrolled. All patients involved in the study will undergo SD-OCT, eye tracking, gait and balance assessments, blood draw for genomics and fluid biomarkers, neuropsychological assessment, brain MRI and brain amyloid PET.
Group III: Mild Cognitive Impairment (VCI)Experimental Treatment1 Intervention
Sixty-five subjects meeting the National Institute on Aging-Alzheimer's Association criteria for amnestic or multi-domain MCI with MoCA score ≥18 will be enrolled. All patients will undergo SD-OCT, eye tracking, gait and balance assessments, blood draw for genomics and fluid biomarkers, neuropsychological assessment, brain MRI and brain amyloid PET. A subset will undergo SV-OCT.
Group IV: LBD SpectrumExperimental Treatment1 Intervention
Sixty- five subjects with: Dementia with Lewy Bodies (DLB) meeting the criteria for probable Dementia with Lewy Bodies with MMSE score ≥20; or PD-MCI meeting the proposed Level I criteria for Mild Cognitive Impairment in Parkinson's Disease with MoCA score 18-24; or; PDD meeting the criteria for probable Parkinson's Disease - Dementia and MMSE score ≥20 will be enrolled. All patients involved will undergo SD-OCT, eye tracking, gait and balance assessments, blood draw for genomics and fluid biomarkers, neuropsychological assessment, brain MRI and brain amyloid PET. A subset will undergo SV-OCT.
Group V: Alzheimer's Disease (AD)Experimental Treatment1 Intervention
Sixty-five subjects meeting the National Institute on Aging-Alzheimer's Association (NIA-AA) core clinical criteria for probable AD dementia will be enrolled. All patients will undergo SD-OCT, eye tracking, gait and balance assessments, blood draw for genomics and fluid biomarkers, neuropsychological assessment, brain MRI and brain amyloid PET. A subset will undergo SV-OCT.

Find a Location

Who is running the clinical trial?

Weston Brain InstituteOTHER
11 Previous Clinical Trials
628 Total Patients Enrolled
GE HealthcareIndustry Sponsor
295 Previous Clinical Trials
633,221 Total Patients Enrolled
1 Trials studying Lewy Body Disease
326 Patients Enrolled for Lewy Body Disease
University Health Network, TorontoOTHER
1,514 Previous Clinical Trials
499,860 Total Patients Enrolled
1 Trials studying Lewy Body Disease
500 Patients Enrolled for Lewy Body Disease
~16 spots leftby Mar 2025
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