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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 : 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

Tracking Information
First Submitted Date April 27, 2017
First Posted Date May 15, 2017
Last Update Posted Date April 28, 2020
Actual Study Start Date April 4, 2016
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 11, 2017)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early-onset Alzheimer's Disease Phenotypes: Neuropsychology and Neural Networks
Official Title Early-onset Alzheimer's Disease Phenotypes: Neuropsychology and Neural Networks
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.
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 Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • 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
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 11, 2017)
180
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2022
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
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
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number 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 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mario F. Mendez, University of California, Los Angeles
Study Sponsor University of California, Los Angeles
Collaborators
  • National Institute on Aging (NIA)
  • University of Southern California
Investigators
Principal Investigator: Mario F Mendez, MD, PhD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date April 2020