Early-onset Alzheimer's Disease Phenotypes: Neuropsychology and Neural Networks

Alzheimer Disease Clinical Trial

— EOAD-Subtype  

Official title:

Early-onset Alzheimer's Disease Phenotypes: Neuropsychology and Neural Networks

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03153371
• Other study ID #: 1RF1AG050967
• Secondary ID: UCLA IRB#16-0004
• Status: Recruiting
• Start date: April 4, 2016
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2020
• Source: University of California, Los Angeles
• Contact: Youssef I Khattab, BA
• Phone: (310)-478-3711
• Email: YKhattab[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Early Onset
• Alzheimer Disease, Late Onset
• Aphasia
• Aphasia, Primary Progressive
• Apraxias
• Corticobasal Degeneration
• Dementia
• Dementia, Alzheimer Type
• Executive Dysfunction
• Frontotemporal Dementia
• Ideomotor Apraxia
• Logopenic Progressive Aphasia
• Pick Disease of the Brain
• Posterior Cortical Atrophy
• Primary Progressive Aphasia
• Visuospatial/Perceptual Abilities

Locations

Country	Name	City	State
United States	UCLA Department of Neurology	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Aging (NIA), University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

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