- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03153371
Early-onset Alzheimer's Disease Phenotypes: Neuropsychology and Neural Networks (EOAD-Subtype)
Study Overview
Status
Detailed Description
Unlike the usual late-onset Alzheimer's disease (LOAD), early-onset AD (EOAD), with onset before age 65, includes a high percentage of phenotypic variants. These non-familial, variants (vEOAD) present, not with progressive memory loss, but with language, visuospatial, or other cognitive difficulties. AD is now understood as a disorder that manifests with disturbed cognition reflecting disturbed neural networks. A multivariate analysis of neuropsychological tests, the "gold standard" for objectively defining neurocognitive impairments, coupled with structural and functional neuroimaging analysis of connectomes, can identify the neurocognitive-neural network profiles of vEOAD patients, compared to those with typical AD. This knowledge can increase our understanding of the heterogeneity of AD and how it causes disease.
This study hopes to show that vEOAD constitutes a "Type 2 AD", by (1) defining the neuropsychological components of Type 2 AD, and (2) understanding the anatomy and atrophy of the brains of vEOAD patients. Together, these components can outline the neurocognitive-neural network profile of Type 2 AD.
In addition to information that can help in the diagnosis and management of EOAD, this study can stimulate novel research into the reasons for this neurobiological heterogeneity in AD and could potentially lead to interventions based on alternate neurocognitive-neural network profiles.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Youssef I Khattab, BA
- Phone Number: 48176 (310)-478-3711
- Email: YKhattab@mednet.ucla.edu
Study Contact Backup
- Name: Elivra E Jimenez, PhD
- Phone Number: 40584 or 43389 (310)-478-3711
- Email: eljimenez@mednet.ucla.edu
Study Locations
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California
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Los Angeles, California, United States, 90095
- Recruiting
- UCLA Department of Neurology
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Contact:
- Youssef I Khattab, BA
- Phone Number: 48176 310-478-3711
- Email: YKhattab@mednet.ucla.edu
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Contact:
- Elvira E Jimenez, PhD
- Phone Number: 40584 or 43389 (310)-478-3711
- Email: eljimenez@mednet.ucla.edu
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Principal Investigator:
- Mario F Mendez, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria for patients with Alzheimer's disease (AD):
- Meet criteria for AD.
- Meet clinical criteria for either typical amnestic AD or variant phenotypes of early-onset (EOAD, or "Type 2 AD").
- Mild-moderate dementia severity
- Sufficient English fluency to complete neuropsychological testing in English.
- Ability to provide consent for participation, or willingness to provide assent and a legally-authorized representative willing to provide surrogate consent.
- Availability of a caregiver informant for participation
Exclusion criteria for patients with Alzheimer's disease (AD):
- Complicating medical illnesses.
- Significant primary visual impairments.
- Major psychiatric illness not due to the dementia.
- Confounding medications.
Inclusion criteria for control participants:
- Score 28/30 or higher on the Folstein Mini-Mental Status Exam.
- Age 40-85 years old
- Able to provide consent for participation and express willingness to participate in one-year follow-up visits.
- Have sufficient English fluency to complete neuropsychological testing in English.
Exclusion criteria for control participants:
- Complicating medical illnesses.
- Significant primary visual impairments.
- Major psychiatric illness not due to the dementia.
- Confounding medications.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Early-onset Alzheimer's disease
This group will include 90 patients who have been diagnosed with clinically probable early-onset Alzheimer's disease by the UCLA Neurology Clinic (60 variant phenotypes; 30 typical amnestic).
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Alzheimer's disease
This group will include 30 patients who have been diagnosed with clinically probable Alzheimer's disease (typical late-onset AD)
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Controls
Healthy age-matched individuals without clinically significant cognitive impairments will be enrolled into this study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alzheimer's disease Subtype
Time Frame: Performed at baseline
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Neuropsychological testing results for use in a two-stage multivariate diagnostic method that combines the (weighted) test results in order to best discriminate Type 2 AD and typical AD.
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Performed at baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in overall Neurological profile
Time Frame: Performed at baseline and 1-year follow-up visit
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Change in performance on neurological tasks between baseline visit and follow-up visit.
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Performed at baseline and 1-year follow-up visit
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Brain atrophy in MRI - Magnetic Resonance Imaging of the brain
Time Frame: Performed at baseline visit
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Images from initial MRI scan taken at baseline visit will be analyzed for atrophy and white matter tract integrity
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Performed at baseline visit
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Change in overall Neuropsychological profile
Time Frame: Performed at baseline and 1-year follow-up visit
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Change in neuropsychological performance over time.
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Performed at baseline and 1-year follow-up visit
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Collaborators and Investigators
Investigators
- Principal Investigator: Mario F Mendez, MD, PhD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Disease Attributes
- Neurodegenerative Diseases
- Psychomotor Disorders
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Tauopathies
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Dementia
- Alzheimer Disease
- Aphasia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
- Apraxias
- Apraxia, Ideomotor
- Late Onset Disorders
Other Study ID Numbers
- 1RF1AG050967 (U.S. NIH Grant/Contract)
- UCLA IRB#16-000496 (Other Identifier: UCLA Institutional Research Board)
- 1RF1AG050967-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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