COMPLETED

Atlas of Retinal Imaging in Alzheimer's Study

Conditions

Alzheimer Disease Mild Cognitive Impairment Mild Dementia Aging Cognitive Change retina Alzheimer cognitive aging biomarker preclinical Alzheimer's disease ophthalmology neurology

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The Atlas of Retinal Imaging in Alzheimer's (ARIAS) study is a 5-year study examining the natural history of retinal imaging biomarkers associated with disease risk, disease burden, and disease progression in Alzheimer's disease (AD). The objective of this project is to create a 'gold standard' reference database of structural anatomic and functional imaging of the retina, in order to enable the identification and development of both sensitive and reliable markers of AD risk and/or progression. Our ultimate goal is to develop a new screening protocol that identifies changes related to AD 10-20 years before AD is clinically visible.

Official Title

Atlas of Retinal Imaging in Alzheimer's Study

Quick Facts

Study Start:2019-12-16

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03862222

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* · Patients with histories of other ocular or neurologic disease that could affect the results, such as unusually high refractive errors ( \> or \< 5.0 diopters native spherical equivalent), age related macular degeneration, diabetic retinopathy, hypertensive retinopathy, retinal vascular disease, glaucoma, optic nerve disease, cystic macular edema, large cataracts or corneal disease that may preclude visualization of the retinal fundus, substantial ocular media opacity, and/or intraocular surgery within 90 days of any study visit will be excluded. * History of severe brain injury or other known neurologic disease or insult, which, as described by medical records, and/or as determined by the PI's clinical judgment, has resulted in lasting cognitive sequelae that would confound the assessment and staging of potential neurodegenerative disease. * Geriatric Depression Scale Short Form (GDS-S 15 Items) score \> 6. * Poorly controlled major depression or another psychiatric disorder within the past year. * History of alcohol or substance abuse and/or dependence within the past 2 years (DSM-V criteria). * History of schizophrenia or a history of psychotic features, agitation or behavioral problems within the last 3 months, which could lead to difficulty complying with the protocol. * Participants who, in the investigator's opinion, will not comply with study procedures. * Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol including: * History of systemic cancer within the past 5 years (non-metastatic skin cancers are acceptable). * History of clinically significant liver disease, coagulopathy, or vitamin K deficiency within the past 2 years. * History of myocardial infarction within the past six (6) months or unstable or severe cardiovascular disease including angina or congestive heart failure (CHF) with symptoms at rest. * History of stroke(s) with lasting impairment to vision or the visual system, coagulopathy, uncontrolled hypertension (i.e., systolic BP \> 170 or diastolic BP \> 100) and uncontrolled or insulin requiring diabetes. Blood pressure will be recorded on the day of each examination. * Evidence of enlarged ventricles and/or normal pressure hydrocephalus on review of medical records or inspection of CT/MRI of the brain based on previous clinical diagnosis (MRI) as noted in their neurological history * History of Parkinson's disease, Parkinsonism due to multiple system atrophy (MSA), progressive supranuclear palsy (PSP), Shy Drager Syndrome (SDS) or other neuro-degenerative dementias * History of symptoms of narrow-angle glaucoma (warning signs include eye pain, restricted vision, blurred vision) * History of elevated intraocular pressure, or medical record evidence of intraocular pressure \> 20 mm Hg * Regular (daily) use of narcotics or antipsychotic medications. * New use of anti-Parkinsonian medications (e.g., sinemet, amantaine, bromocriptine, pergolide and selegiline) within 2 months prior to screening. * New use of anti-convulsants (e.g., phenytoin, phenobarbital, carbamazepine) within 2 months prior to screening. * New use of centrally active beta-blockers, narcotics, methyldopa and clonidine within 4 weeks prior to screening. * New use of neuroleptics or narcotic analgesics within 4 weeks prior to screening. * New and chronic use of long-acting benzodiazepines or barbiturates within 4 weeks prior to screening. * Use of short-acting anxiolytics or sedative-hypnotics more frequently than 2 times per week within 4 weeks prior to screening (note: sedative agents should not be used within 72 hours of the baseline and follow-up visits). * Initiation or change in dose of an antidepressant lacking significant cholinergic side effects within the 4 weeks prior to screening (use of stable doses of antidepressants for at least 4 weeks prior to screening is acceptable) * An anticholinergic burden score of \>3 on the Anticholinergic Cognitive Burden Scale (see appendix item 9.19). * Known hypersensitivity to anticholinergic medications, including tropicamide eye drops.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* · Patients with histories of other ocular or neurologic disease that could affect the results, such as unusually high refractive errors ( \> or \< 5.0 diopters native spherical equivalent), age related macular degeneration, diabetic retinopathy, hypertensive retinopathy, retinal vascular disease, glaucoma, optic nerve disease, cystic macular edema, large cataracts or corneal disease that may preclude visualization of the retinal fundus, substantial ocular media opacity, and/or intraocular surgery within 90 days of any study visit will be excluded.
* History of severe brain injury or other known neurologic disease or insult, which, as described by medical records, and/or as determined by the PI's clinical judgment, has resulted in lasting cognitive sequelae that would confound the assessment and staging of potential neurodegenerative disease.
* Geriatric Depression Scale Short Form (GDS-S 15 Items) score \> 6.
* Poorly controlled major depression or another psychiatric disorder within the past year.
* History of alcohol or substance abuse and/or dependence within the past 2 years (DSM-V criteria).
* History of schizophrenia or a history of psychotic features, agitation or behavioral problems within the last 3 months, which could lead to difficulty complying with the protocol.
* Participants who, in the investigator's opinion, will not comply with study procedures.
* Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol including:
* History of systemic cancer within the past 5 years (non-metastatic skin cancers are acceptable).
* History of clinically significant liver disease, coagulopathy, or vitamin K deficiency within the past 2 years.
* History of myocardial infarction within the past six (6) months or unstable or severe cardiovascular disease including angina or congestive heart failure (CHF) with symptoms at rest.
* History of stroke(s) with lasting impairment to vision or the visual system, coagulopathy, uncontrolled hypertension (i.e., systolic BP \> 170 or diastolic BP \> 100) and uncontrolled or insulin requiring diabetes. Blood pressure will be recorded on the day of each examination.
* Evidence of enlarged ventricles and/or normal pressure hydrocephalus on review of medical records or inspection of CT/MRI of the brain based on previous clinical diagnosis (MRI) as noted in their neurological history
* History of Parkinson's disease, Parkinsonism due to multiple system atrophy (MSA), progressive supranuclear palsy (PSP), Shy Drager Syndrome (SDS) or other neuro-degenerative dementias
* History of symptoms of narrow-angle glaucoma (warning signs include eye pain, restricted vision, blurred vision)
* History of elevated intraocular pressure, or medical record evidence of intraocular pressure \> 20 mm Hg
* Regular (daily) use of narcotics or antipsychotic medications.
* New use of anti-Parkinsonian medications (e.g., sinemet, amantaine, bromocriptine, pergolide and selegiline) within 2 months prior to screening.
* New use of anti-convulsants (e.g., phenytoin, phenobarbital, carbamazepine) within 2 months prior to screening.
* New use of centrally active beta-blockers, narcotics, methyldopa and clonidine within 4 weeks prior to screening.
* New use of neuroleptics or narcotic analgesics within 4 weeks prior to screening.
* New and chronic use of long-acting benzodiazepines or barbiturates within 4 weeks prior to screening.
* Use of short-acting anxiolytics or sedative-hypnotics more frequently than 2 times per week within 4 weeks prior to screening (note: sedative agents should not be used within 72 hours of the baseline and follow-up visits).
* Initiation or change in dose of an antidepressant lacking significant cholinergic side effects within the 4 weeks prior to screening (use of stable doses of antidepressants for at least 4 weeks prior to screening is acceptable)
* An anticholinergic burden score of \>3 on the Anticholinergic Cognitive Burden Scale (see appendix item 9.19).
* Known hypersensitivity to anticholinergic medications, including tropicamide eye drops.

Contacts and Locations

Principal Investigator

Stuart Sinoff, MD

PRINCIPAL_INVESTIGATOR

BayCare Health System

Peter J Snyder, PhD

PRINCIPAL_INVESTIGATOR

University of Rhode Island

Study Locations (Sites)

Morton Plant Hospital

Clearwater, Florida, 33756

United States

St. Anthony's Hospital

Saint Petersburg, Florida, 33705

United States

University of Rhode Island

Kingston, Rhode Island, 02881

United States

Butler Hospital

Providence, Rhode Island, 02906

United States

Collaborators and Investigators

Sponsor: University of Rhode Island

Stuart Sinoff, MD, PRINCIPAL_INVESTIGATOR, BayCare Health System
Peter J Snyder, PhD, PRINCIPAL_INVESTIGATOR, University of Rhode Island

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-16

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2019-12-16

Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

retina
Alzheimer
cognitive aging
biomarker
preclinical Alzheimer's disease
ophthalmology
neurology

Additional Relevant MeSH Terms

Alzheimer Disease
Mild Cognitive Impairment
Mild Dementia
Aging
Cognitive Change