Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03153371
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : April 28, 2020
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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

  3. Change in overall Neuropsychological profile [ Time Frame: Performed at baseline and 1-year follow-up visit ]
    Change in neuropsychological performance over time.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Youssef I Khattab, BA (310)-478-3711 ext 48176 YKhattab@mednet.ucla.edu
Contact: Elivra E Jimenez, PhD (310)-478-3711 ext 40584 or 43389 eljimenez@mednet.ucla.edu

Locations
Layout table for location information
United States, California
UCLA Department of Neurology Recruiting
Los Angeles, California, United States, 90095
Contact: Youssef I Khattab, BA    310-478-3711 ext 48176    YKhattab@mednet.ucla.edu   
Contact: Elvira E Jimenez, PhD    (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
Layout table for investigator information
Principal Investigator: Mario F Mendez, MD, PhD University of California, Los Angeles
  Study Documents (Full-Text)

Documents provided by Mario F. Mendez, University of California, Los Angeles:
Informed Consent Form  [PDF] December 19, 2019

More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Mario F. Mendez, Professor of Neurology and Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03153371    
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: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Aphasia
Apraxias
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Apraxia, Ideomotor
Late Onset Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
 Neurocognitive Disorders
Mental Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Psychomotor Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Disease Attributes
Pathologic Processes