Early-onset Alzheimer's Disease Phenotypes: Neuropsychology and Neural Networks (EOAD-Subtype)

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ClinicalTrials.gov Identifier: NCT03153371

Recruitment Status : Recruiting

First Posted : May 15, 2017

Last Update Posted : May 15, 2017

See Contacts and Locations

Sponsor:

Collaborators:

National Institute on Aging (NIA)

University of Southern California

Information provided by (Responsible Party):

Mario F. Mendez, University of California, Los Angeles

Study Description

Brief Summary:

This study attempts to identify two types of AD by using clinical and cognitive tasks and brain imaging. The subtypes of AD are separated into a "typical" group (memory loss) and a "variant" group (language, visuospatial, and other cognitive difficulties). Performance on the clinical tasks and brain imaging will be compared among the young-onset Alzheimer's disease group, a late-onset Alzheimer's disease group, and a control group.

Condition or disease
Alzheimer Disease, Early Onset Alzheimer Disease Alzheimer Disease, Late Onset Dementia, Alzheimer Type Logopenic Progressive Aphasia Primary Progressive Aphasia Visuospatial/Perceptual Abilities Posterior Cortical Atrophy Executive Dysfunction Corticobasal Degeneration Ideomotor Apraxia

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 Design


Study Type :	Observational
Estimated Enrollment :	180 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	Early-onset Alzheimer's Disease Phenotypes: Neuropsychology and Neural Networks
Actual Study Start Date :	April 4, 2016
Estimated Primary Completion Date :	March 31, 2021
Estimated Study Completion Date :	March 31, 2022

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Alzheimer disease GRN-related frontotemporal dementia Frontotemporal dementia with parkinsonism-17

MedlinePlus related topics: Alzheimer's Disease

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease Corticobasal Degeneration Frontotemporal Dementia Frontotemporal Dementia, Ubiquitin-positive Pick's Disease Primary Progressive Aphasia Semantic Dementia Apraxia Logopenic Progressive Aphasia

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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).
Alzheimer's disease This group will include 30 patients who have been diagnosed with clinically probable Alzheimer's disease (typical late-onset AD)
Controls Healthy age-matched individuals without clinically significant cognitive impairments will be enrolled into this study.

Outcome Measures

Primary Outcome Measures :

Alzheimer's disease Subtype [ Time Frame: Performed at baseline ]
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.

Secondary Outcome Measures :

Change in overall Neurological profile [ Time Frame: Performed at baseline and 1-year follow-up visit ]
Change in performance on neurological tasks between baseline visit and follow-up visit.
Brain atrophy in MRI - Magnetic Resonance Imaging of the brain [ Time Frame: Performed at baseline visit ]
Images from initial MRI scan taken at baseline visit will be analyzed for atrophy and white matter tract integrity
Change in overall Neuropsychological profile [ Time Frame: Performed at baseline and 1-year follow-up visit ]
Change in neuropsychological performance over time.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	40 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients with a diagnosis of early-onset Alzheimer's disease (EOAD; with a diagnosis before age 65), including early-onset neurodegenerative conditions such as primary progressive aphasia (PPA), other aphasias (logopenic, semantic, and non-fluent), posterior cortical atrophy (PCA), ideomotor limb apraxias, and executive dysfunction.

Criteria

Inclusion criteria for patients with Alzheimer's disease (AD):
1. Meet criteria for AD.
2. Meet clinical criteria for either typical amnestic AD or variant phenotypes of early-onset (EOAD, or "Type 2 AD").
3. Mild-moderate dementia severity
4. Sufficient English fluency to complete neuropsychological testing in English.
5. Ability to provide consent for participation, or willingness to provide assent and a legally-authorized representative willing to provide surrogate consent.
6. Availability of a caregiver informant for participation
Exclusion criteria for patients with Alzheimer's disease (AD):
1. Complicating medical illnesses.
2. Significant primary visual impairments.
3. Major psychiatric illness not due to the dementia.
4. Confounding medications.
Inclusion criteria for control participants:
1. Score 28/30 or higher on the Folstein Mini-Mental Status Exam.
2. Age 40-85 years old
3. Able to provide consent for participation and express willingness to participate in one-year follow-up visits.
4. Have sufficient English fluency to complete neuropsychological testing in English.
Exclusion criteria for control participants:
1. Complicating medical illnesses.
2. Significant primary visual impairments.
3. Major psychiatric illness not due to the dementia.
4. Confounding medications.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153371

Contacts


Contact: Randy E Desarzant, BA	(310)-478-3711 ext 43621	rdesarzant@mednet.ucla.edu
Contact: Elivra E Jimenez, MPH	(310)-478-3711 ext 40584 or 43389	eljimenez@mednet.ucla.edu

Locations


United States, California
UCLA Department of Neurology	Recruiting
Los Angeles, California, United States, 90095
Contact: Randy E Desarzant, BA 310-478-3711 ext 43621 rdesarzant@mednet.ucla.edu
Contact: Elvira E Jimenez, MPH (310)-478-3711 ext 40584 or 43389 eljimenez@mednet.ucla.edu
Principal Investigator: Mario F Mendez, MD, PhD

Sponsors and Collaborators

University of California, Los Angeles

National Institute on Aging (NIA)

University of Southern California

Investigators


Principal Investigator:	Mario F Mendez, MD, PhD	University of California, Los Angeles

More Information


Responsible Party:	Mario F. Mendez, Professor of Neurology and Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT03153371 History of Changes
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 )
First Posted:	May 15, 2017 Key Record Dates
Last Update Posted:	May 15, 2017
Last Verified:	May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Mario F. Mendez, University of California, Los Angeles:


Alzheimer's disease Young-onset variant visuospatial language apraxia control	dementia memory MRI neurology neuropsychology brain

Additional relevant MeSH terms:


Alzheimer Disease Dementia Atrophy Aphasia Apraxias Aphasia, Primary Progressive Pick Disease of the Brain Frontotemporal Dementia Late Onset Disorders Apraxia, Ideomotor Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases	Neurocognitive Disorders Mental Disorders Pathological Conditions, Anatomical Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Psychomotor Disorders Frontotemporal Lobar Degeneration TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases Disease Attributes

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