Alzheimer Disease, Early OnsetEOAD-SubtypeNCT03153371
Early-onset Alzheimer's Disease Phenotypes: Neuropsychology and Neural Networks
An observational study of Alzheimer Disease, Early Onset and Alzheimer Disease, run by University of California, Los Angeles at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Early Onset, Alzheimer Disease, Alzheimer Disease, Late Onset
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2016to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Complicating medical illnesses.
- Significant primary visual impairments.
- Major psychiatric illness not due to the dementia.
- Confounding medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Department of Neurology
Los Angeles, California, 90095
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease, Early Onset, Alzheimer Disease, Alzheimer Disease, Late Onset, Dementia, Alzheimer Type, Logopenic Progressive Aphasia, Primary Progressive Aphasia
- Keywords
- Alzheimer's disease, Young-onset, variant, visuospatial, language, apraxia, control, dementia, memory, MRI, neurology, neuropsychology, brain
- Medical subject headings
- Alzheimer Disease, Aphasia, Primary Progressive, Corticobasal Degeneration, Apraxia, Ideomotor, Language, Apraxias, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Performed at baseline
Secondary outcomes (3)
Change in overall Neurological profile
Change in performance on neurological tasks between baseline visit and follow-up visit.
Measured: Performed at baseline and 1-year follow-up visit
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
Measured: Performed at baseline visit
Change in overall Neuropsychological profile
Change in neuropsychological performance over time.
Measured: Performed at baseline and 1-year follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start4 Apr 2016
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Early OnsetStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Southern California
- Responsible party
- Principal investigator, Mario F. Mendez, University of California, Los Angeles
- Investigators
- Mario F Mendez, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153371
- Sponsor's protocol ID
- 1RF1AG050967
- Other IDs
- UCLA IRB#16-000496, 1RF1AG050967-01A1
- Acronym
- EOAD-Subtype
- Status last verified
- Apr 2025
- First submitted
- 27 Apr 2017
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-onset Alzheimer's Disease Phenotypes: Neuropsychology and Neural Networks
- ClinicalTrials.gov ID
- NCT03153371
- Acronym / sponsor ID
- EOAD-Subtype / 1RF1AG050967
- Conditions
- Alzheimer Disease, Early Onset, Alzheimer Disease, Alzheimer Disease, Late Onset, Dementia, Alzheimer Type, Logopenic Progressive Aphasia, Primary Progressive Aphasia
- Keywords
- Alzheimer's disease, Young-onset, variant, visuospatial, language, apraxia, control, dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Southern California
- Study start
- 4 Apr 2016 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Change in overall Neurological profile
Time frame: Performed at baseline and 1-year follow-up visit
Brain atrophy in MRI - Magnetic Resonance Imaging of the brain
Time frame: Performed at baseline visit
Change in overall Neuropsychological profile
Time frame: Performed at baseline and 1-year follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario F Mendez, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, Early Onset and Alzheimer Disease, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's disease Subtype (time frame: Performed at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.