NCT03153371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

5.4 years

First QC Date

April 27, 2017

Last Update Submit

April 28, 2025

Conditions

Keywords

Alzheimer's diseaseYoung-onsetvariantvisuospatiallanguageapraxiacontroldementiamemoryMRIneurologyneuropsychologybrain

Outcome Measures

Primary Outcomes (1)

  • Alzheimer's disease Subtype

    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.

    Performed at baseline

Secondary Outcomes (3)

  • Change in overall Neurological profile

    Performed at baseline and 1-year follow-up visit

  • Brain atrophy in MRI - Magnetic Resonance Imaging of the brain

    Performed at baseline visit

  • Change in overall Neuropsychological profile

    Performed at baseline and 1-year follow-up visit

Study Arms (3)

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.

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Complicating medical illnesses.
  • Significant primary visual impairments.
  • Major psychiatric illness not due to the dementia.
  • Confounding medications.
  • 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.
  • Complicating medical illnesses.
  • Significant primary visual impairments.
  • Major psychiatric illness not due to the dementia.
  • Confounding medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Department of Neurology

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseAphasia, Primary ProgressiveCorticobasal DegenerationApraxia, IdeomotorLanguageApraxiasDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersAphasiaSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPsychomotor DisordersCommunicationBehavior

Study Officials

  • Mario F Mendez, MD, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology and Psychiatry

Study Record Dates

First Submitted

April 27, 2017

First Posted

May 15, 2017

Study Start

April 4, 2016

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations