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Mild Cognitive ImpairmentA3PMNCT02089555

African American Alzheimer's Progression Markers - CSF and Neuro-Imaging

An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

African Americans are twice as likely to develop Alzheimer's disease as white Americans, but few African Americans are enrolled in large Alzheimer's biomarker studies. The current proposal aims to determine the influence of Alzheimer's disease and vascular disease on memory and aging in African Americans through… Read more about this study

Who is it for?
Ages 60 to 85 yearsHealthy volunteers can take part
What is being tested?
Lumbar puncture, Blood draw and Magnetic Resonance Imaging (MRI)
Type of treatment
Surgery or procedure
How many people
135 participants
Where
1 siteUnited States
Study dates
Sep 2013to Jun 2016
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 60 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: African American and non-Hispanic white seniors with normal cognition, mild cognitive impairment (MCI), or mild Alzheimer's disease.

Who may be able to join

  • Ages 60-85.
  • Has normal cognition, a diagnosis of mild cognitive impairment, or a diagnosis of Alzheimer's disease or mild cognitive impairment.
  • Self-reported race of African American or non-Hispanic white.
  • Able to undergo neuropsychological testing, lumbar puncture, and MRI.
  • English speaking.

Who cannot join

  • History of stroke.
  • Diagnosis of Parkinson's disease, amyotrophic lateral sclerosis, or another progressive neurological disorder which may spare cognition.
  • Mini-Mental State Examination (MMSE) < 17

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Emory University

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Biomarkers for Alzheimer's Disease and Mild Cognitive Impairment in African Americans and Caucasians

African Americans are twice as likely to develop Alzheimer's disease as white Americans, but few African Americans are enrolled in large Alzheimer's biomarker studies. The current proposal aims to determine the influence of Alzheimer's disease and vascular disease on memory and aging in African Americans through modern biomarkers (spinal fluid, MRI, and amyloid imaging), and how these may differ between African Americans and white Americans in preparation for a large multi-center study of aging in African American.

Read the detailed description

African Americans represent about 10% of the population in the US, but are under-represented in biomarker-related aging studies such as the Alzheimer's Disease Neuro-imaging Initiative (ADNI) and World Wide ADNI. Epidemiologic studies show that, compared to non-Hispanic white (NHW) Americans, African Americans (AA) are more likely to develop mild cognitive impairment (MCI) and Alzheimer's disease (AD), have different genetic risks of developing AD, and experience different rates of cognitive decline after cognitive symptoms develop. All these point to the existence of an MCI/AD endophenotype for AA, although few of these epidemiological studies involve modern chemical or imaging biomarkers associated with AD pathology and progression. Preliminary studies using AA subjects who have undergone CSF analysis (n=36) show that AA MCI subjects are more likely to have normal CSF AD biomarkers than NHW MCI subjects, yet at the same time greater hippocampal atrophy on MRI. The investigators hypothesize that endothelial dysfunction is an alternate mechanism which independently contributes to cognitive impairment in AA subjects with sub-threshold AD pathology in a race-independent fashion, and endothelia dysfunction further enhances the neurotoxicity of AD-associated brain changes in a race-dependent fashion. The investigators propose to build on their success in recruiting AA volunteers into memory and aging studies at the Emory's Registry for Remembrance to recruit a cross-sectional cohort of 75 AA subjects along with 75 NHW subjects with normal cognition, MCI, or mild AD. They will test this hypothesis through two aims. In Aim 1, they will determine whether endothelial dysfunctions independently contribute to cognitive decline in AA and NHW subjects by measuring cerebrospinal fluid (CSF) levels of AD, endothelial, and inflammatory markers. Each subject will also undergo MRI analysis for total area of white matter hyperintensities as an imaging marker of endothelial dysfunction. Based on the hypothesis, they predict that AA MCI/AD subjects are more likely than NHW MCI subjects to have normal CSF AD biomarkers, abnormal CSF endothelial markers, and greater number and area of white matter hyperintensities on MRI. In Aim 2, the investigators will determine if an endothelial marker - intercellular adhesion molecule 1 or ICAM-1 - gene variant unique to AA enhances AD neurotoxicity to explain the greater hippocampal atrophy among AA MCI subjects. The Lys56Met ICAM1 gene variant associated with low ICAM-1 levels is uniquely found in 16-20% of AA, and these subjects may have impaired downstream activation of neprilysin, an Abeta-degrading enzyme. If the hypothesis is true, AA subjects with the Lys56Met gene variant will be more likely to have hippocampal atrophy, temporal-parietal cerebral hypoperfusion, and cerebral amyloid deposition than AA subjects and NHW subjects without the gene variant. This may occur in the setting of CSF Abeta2 pseudo-normalization if low neprilysin levels lead to increased Abeta42 levels. Successful completion of the current proposal will confirm the preliminary finding of a unique AA endophenotype within the broader AD-spectrum disorders, directly examine whether endothelial dysfunctions additively and synergistically lead to cognitive decline in AD among AA in a cross-sectional cohort, and help power and design a future a multi-center, multi-racial longitudinal biomarker study to validate these cross-sectional findings.

Being tested
Lumbar puncture, Blood draw, Magnetic Resonance Imaging (MRI)
Medical subject headings
Cognitive Dysfunction, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lumbar punctureProcedure or surgery

    Also called Spinal tap

    Cerebrospinal fluid (CSF) will be collected via lumbar puncture. During lumbar puncture, a needle is inserted between two lumbar bones (vertebrae) to remove a sample of cerebrospinal fluid. The procedure involves inserting a thin, hollow needle between the two lower vertebrae (lumbar region), through the spinal membrane (dura) and into the spinal canal and extracting a small amount of fluid. The procedure takes about 45 minutes.

  • Blood drawProcedure or surgery

    One tube of blood will be collected in an ethylenediaminetetraacetic acid (EDTA)-K2 plasma tube for DNA analysis.

  • Magnetic Resonance Imaging (MRI)Procedure or surgery

    Each participant will undergo Magnetic Resonance Imaging (MRI) analysis using a modified Alzheimer's Disease Neuroimaging Initiative (ADNI) protocol with a 3 Tesla (3T) MRI Scan. The exam takes approximately 20 minutes.

Study groups in NCT02089555
Study groupRoleWhat they receive
African AmericansThis group consists of African American (AA) individuals aged 65-80 who are part of the Emory Alzheimer's Disease Research Center (ADRC) (a multi-racial cohort of subjects with normal cognition, Mild Cognitive Impairment (MCI) or mild Alzheimer's Disease (AD)) or the Registry for Remembrance (RfR) (a community of AA individuals who are interested in studies of memory and aging). AA and Non-Hispanic White (NHW) participants will be frequency-matched for age, gender, and education within each cognitive category (35 with normal cognition, 30 with MCI, and 10 with mild AD for each race).
Receives: Procedure: Lumbar puncture; Procedure: Blood draw; Procedure: Magnetic Resonance Imaging (MRI)
Non-Hispanic WhitesThis group consists of Non-Hispanic White (NHW) individuals aged 65-80 who are part of the Emory Alzheimer's Disease Research Center (ADRC) (a multi-racial cohort of subjects with normal cognition, Mild Cognitive Impairment (MCI) or mild Alzheimer's Disease (AD)). African American (AA) and Non-Hispanic White (NHW) participants will be frequency-matched for age, gender, and education within each cognitive category (35 with normal cognition, 30 with MCI, and 10 with mild AD for each race).
Receives: Procedure: Lumbar puncture; Procedure: Blood draw; Procedure: Magnetic Resonance Imaging (MRI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CSF endothelial marker levels

    Measured: one time only

  2. CSF Alzheimer's biomarker levels

    Measured: one time only

Secondary outcomes (2)
  1. MRI evidence of small vessel disease

    Measured: one time only

  2. MRI evidence of brain atrophy

    Measured: one time only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2014 (estimated)
  2. Study startSep 2013
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

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
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02089555
Sponsor's protocol ID
IRB00066145
Other IDs
R21AG043885
Acronym
A3PM
Status last verified
Jun 2016
First submitted
14 Mar 2014
Last updated
23 Jun 2016
Results posted
No
Data monitoring committee
No

Publications

  • Howell JC, Watts KD, Parker MW, Wu J, Kollhoff A, Wingo TS, Dorbin CD, Qiu D, Hu WT. Race modifies the relationship between cognition and Alzheimer's disease cerebrospinal fluid biomarkers. Alzheimers Res Ther. 2017 Nov 2;9(1):88. doi: 10.1186/s13195-017-0315-1.

    PubMed 29096697

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by Emory University 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 5 inclusion and 3 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 23 Jun 2016. 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?

CSF endothelial marker levels (time frame: one time only). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02089555, which also lists 1 linked publication.

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 23 Jun 2016.

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