BEAM: Brain-Eye Amyloid Memory Study

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT02524405
• Date of registration: 13/08/2015
• Prospective Registration: Yes
• Primary sponsor: Sunnybrook Health Sciences Centre
• Public title: BEAM: Brain-Eye Amyloid Memory Study BEAM
• Scientific title: The Brain Eye Amyloid Memory (BEAM) Study: Validation of Ocular Measures as Potential Biomarkers for Early Detection of Brain Amyloid and Neurodegeneration
• Date of first enrolment: February 2016
• Target sample size: 345
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02524405
• Study type: Observational

Countries of recruitment

Canada

Contacts

• Name: Sandra Black, MD
• Affiliation: Sunnybrook Health Sciences Center

• Name: Sandra E Black, MD

Key inclusion & exclusion criteria

General Inclusion Criteria (All Subgroups)

Participants must meet each of the following criteria for enrolment into the study:

1. Written informed consent obtained and documented

2. Male or post-menopausal female (minimum of one year since the last menstrual period)

3. 50-90 years of age

4. Self-reported proficiency in speaking and understanding spoken English questions

5. =8 years education

6. Capable of cooperating for the duration of the study procedures and assessments

7. Willing to undergo study procedures and remain unaware of the results (unless there
are findings that are of clinical significance and would require further action, in
the opinion of the study physician)

8. Sufficient vision to participate in cognitive testing (corrected near visual acuity of
Snellen 20/70 in at least one eye) and eye-tracking (able to identify symbols and
stimuli presented on a computer screen in front of them)

9. Sufficient corrected hearing to participate in cognitive testing

10. Good venous access for phlebotomy to be performed

11. Able to walk, with or without an assistive aid (e.g., cane, walker)

Subgroup-Specific Inclusion Criteria

Cognitively Normal Controls

1. Cognitively normal and functionally independent in pre-screening history

2. Within normal limits on the TorCA (formally known as Behavioural Neurology Assessment
- Revised (BNA-R)

3. Within normal limits on the study neuropsychological battery

Mild Cognitive Impairment (MCI)

1. Meets the National Institute on Aging-Alzheimer's Association criteria for single or
multi-domain amnestic MCI

2. Impairment of episodic memory plus or minus other cognitive domains on the TorCA

3. Montreal Cognitive Assessment (MoCA) score =18

4. Mini-Mental State Examination (MMSE) > 20

5. In the opinion of the investigator if required: reliable and capable partner who has
regular interaction with them, can provide a collateral history, can assist in
compliance with study procedures, and who is willing to act as the Study Partner
(provide written informed consent) and remain unaware of the results

Alzheimer's Disease (AD)

1. Meets the National Institute on Aging-Alzheimer's Association (NIA-AA) core clinical
criteria for probable or possible AD dementia

2. Mild early AD stage, as defined by MMSE score =18, Atypical cases with a MoCA = 14
will also be allowed.

3. Impairment in two or more cognitive domains on the TorCA

4. Reliable and capable partner who has regular interaction with them, can provide a
collateral history, can assist in compliance with study procedures, and who is willing
to act as the Study Partner (provide written informed consent) and remain unaware of
the results

Lewy Body Disease (LBD) Spectrum PD-MCI

1. Meets the proposed Level I criteria for Mild Cognitive Impairment in Parkinson's
Disease

2. MMSE score =20

3. MoCA score =18

4. Hoehn & Yahr stage 1-3

5. Reliable and capable partner who has regular interaction with them, can provide a
collateral history, can assist in compliance with study procedures, and who is willing
to act as the Study Partner (provide written informed consent) and remain unaware of
the results

LBD-MCI

1. Meets the criteria for Dementia with Lewy Bodies (McKeith et al, 2017 in press)but has
preserved daily functioning

2. MMSE score =20

3. MoCA score =18

4. Hoehn & Yahr stage =3

5. Reliable and capable partner who has regular interaction with them, can provide a
collateral history, can assist in compliance with study procedures, and who is willing
to act as the Study Partner (provide written informed consent) and remain unaware of
the results

Dementia with Lewy Bodies (DLB)

1. Meets the criteria for probable or possible Dementia with Lewy Bodies (McKeith et al,
2017 in press)

2. MMSE score =14

3. MoCA score =25

4. Reliable and capable partner who has regular interaction with them, can provide a
collateral history, can assist in compliance with study procedures, and who is willing
to act as the Study Partner (provide written informed consent) and remain unaware of
the results

PDD

1. Meets the criteria for probable Parkinson's Disease - Dementia

2. MMSE score =18

3. MoCA score =25

4. Hoehn & Yahr stage =4

5. Reliable and capable partner who has regular interaction with them, can provide a
collateral history, can assist in compliance with study procedures, and who is willing
to act as the Study Partner (provide written informed consent) and remain unaware of
the results

Subcortical Vascular Cognitive Impairment (VCI)

1. Presence of subcortical vascular disease, indicated by the following:

i. Periventricular Fazekas score = 3, with or without subcortical lacunes or small
cortical infarcts (<1.5 cm in longest diameter); or ii. Fazekas score = 2, with 2 or
more subcortical lacunes or small cortical infarcts (<1.5 cm in longest diameter); or
iii. Fazekas score = 0 or 1, with 3 subcortical lacunar infarcts (<1.5 cm in
diameter), at least 1 in each hemisphere; or

iv. Probable or possible Cerebral Amyloid Angiopathy using the Modified Boston
Criteria

2. Reliable and capable partner who has regular interaction with them, can provide a
collateral history, can assist in compliance with study procedures, and who is willing
to act as the Study Partner (provide written informed consent) and remain unaware of
the results

Exclusion criteria General Exclusion Criteria (All Subgroups)

Participants who exhibit any of the following conditions will be excluded from the study:

1. Underlying conditions (other than the disease being studied) which in the opinion of
the investigator may interfere with the participant's ability to participate in the
study or may compromise study results, including but not limited to:

1. Unstable cardiac, pulmonary, renal, hepatic, endocrine (i.e. diabetes) or
hematologic disease

2. Active malignancy or infectious disease

3. Significant psychiatric illness, including life-long depressive illness

4. History of significant learning disability

5. Significant other neurologic disease (e.g., multiple sclerosis, Huntington's
disease, normal pressure hydrocephalus, brain tumor,


Age minimum: 50 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lewy Body Disease

Parkinson's Disease

Alzheimer's Disease

Vascular Cognitive Impairment

Mild Cognitive Impairment

Intervention(s)

Other: Pittsburgh Compound B [11C]-PIB

Primary Outcome(s)

Amyloid Depostition [Time Frame: One-time assessment]

Retinal nerve fiber layer thickness [Time Frame: One-time assessment]

Secondary Outcome(s)

Retinal artery narrowing [Time Frame: One-time assessment]

Retinal venular widening [Time Frame: One-time assessment]

Secondary ID(s)

221-2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Weston Brain Institute

GE Healthcare

Baycrest

Centre for Addiction and Mental Health

University Health Network, Toronto

Kensington Eye Institute

Brain Canada

Unity Health Toronto