Wake Forest Alzheimer's Disease Clinical Core (ADCC)
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|ClinicalTrials.gov Identifier: NCT03140865|
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : August 26, 2019
Efforts to find treatments for AD have yielded only modest benefits, likely because longstanding AD pathological processes induce irreversible neurological compromise. These processes begin years before the onset of clinical symptoms. This possibility has been incorporated into a model describing stages of AD development, articulated by the NIA/Alzheimer's Association preclinical workgroup of which the Co-Director of the Kulynych Alzheimer's Research Center, Dr. Suzanne Craft, was a member. According to this model, the best hope for countermanding the effects of AD lies in intervening at the earliest possible point in the pathological cascade. There are several important ongoing efforts in adults with preclinical AD that directly target amyloid aggregation. Although this strategy addresses an important aspect of the AD pathological cascade, we believe that addressing metabolic dysfunction affecting glucose and insulin regulation offers a complementary approach, in that it may reduce amyloid burden and toxicity, while also directly enhancing synaptic health, brain metabolism, tau regulation and neurovascular function.
The purpose of the ADCC is to identify and characterize early risk factors that predict cognitive decline and dementia in asymptomatic adults and adults with early signs of cognitive impairment. The data obtained from this study, collected at enrollment and follow-up will allow us to examine disease trajectory in individuals with and without prediabetes and other measures of glucoregulatory dysfunction in this process. The enrollees, who will be well-characterized with regard to cognitive and metabolic status through ADCC assessments, will provide an important resource for other local (institution) and national investigations. Data collected from participants enrolled in the ADCC will be stored indefinitely for future investigations.
|Condition or disease|
|Alzheimer's Disease Mild Cognitive Impairment Prediabetic State|
The data and specimen repository of the ADCC study will provide a unified mechanism for cataloging and storing data that can be efficiently shared across studies. This repository will also allow for important collaborations with other Alzheimer's Disease Centers across the US that are performing similar investigations of adults at increased risk of dementia. Data sharing across multiple institutions and investigators will be critical to optimize speed of acquisition and standardization of outcomes that may ultimately lead to the development of innovative tools for early detection and new treatment strategies. The repository will include cognitive data, human specimen samples (blood, cerebrospinal fluid), medical and family history information, and neuroimaging data. Data collected from participants enrolled in the ADCC will be stored indefinitely for future investigations.
Participants will include adults at least 55 years old, with or without a cognitive deficit, who meet criteria for inclusion into one of the groups described below. Males and females will be equal to distribution in the Triad area population. Additional recruitment efforts targeting underserved communities will be used to increase representation of these adults in the study cohort beyond what is typical in other local and national studies of AD.
Eligible participants will have the option to participate in the core ADCC study and also in a biomarker-intensive substudy that will collect additional measurements of brain function and chemical markers of AD pathology. While all participants enrolled in the core ADCC study will receive brain magnetic resonance imaging (MRI). Those enrolled in the substudy will complete a lumbar puncture (LP) to permit quantification of AD biomarkers in cerebrospinal fluid (CSF). Participants enrolled in the substudy will be referred to as the Biomarker-Intensive Group, or ADCC-BIG.
At study entry, participants will meet inclusion criteria for membership in one of the groups that differ according to cognitive status and metabolic health (described below). Once enrolled, a change in cognitive or metabolic status will not affect eligibility to receive follow-up assessments as part of this study, although frequency of assessment may change (i.e., enrollees who progress to late-stage AD or type 2 diabetes will not be dis-enrolled). Eligible participants who choose to also enroll in ADCC-BIG must agree to complete the LP. If participants have screened or participated in another Kulynych Center study within the last 3 months, some data may be reused to avoid redundant data collection and reduce participant burden. This data may include specimen samples such as blood or CSF, cognitive testing data and MRI imaging data.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||850 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Wake Forest Alzheimer's Disease Clinical Core|
|Actual Study Start Date :||January 2014|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||June 2021|
This group will include 300 healthy volunteers with no apparent memory problems. Participants will complete an assessment at enrollment and once per year for the following 5 years. In addition to memory assessments at baseline and year 4, participants will have a brain MRI, OGTT A reliable study partner will need to attend the visits or be available via telephone to complete study interviews.
Mild Cognitive Impairment
This group will include 400 volunteers who have mild memory problems that are observed during cognitive testing. Participants will complete an assessment at enrollment and once per year for the following 5 years. In addition to memory assessments at baseline and year 4, participants will have a brain MRI, OGTT A reliable study partner will need to attend the visits or be available via telephone to complete study interviews.
This group will include 150 volunteers with mild stage Alzheimer's disease dementia. Participants will complete an assessment at enrollment and once per year for the following 5 years. In addition to memory assessments at baseline and year 4, participants will have a brain MRI, OGTT A reliable study partner will need to attend visits to complete study interviews.
- Change in performance on cognitive measures. [ Time Frame: 5 years ]Cognitive measure such as memory, verbal fluency and executive function will be assessed annually, either by phone or in person depending on group.
- Change in biomarker levels in cerebrospinal fluid (CSF). [ Time Frame: 5 years ]Biomarkers associated with Alzheimer's will be measured in participants who agree to participate in the Biomarker-Intensive Group.
- Change in brain volumes on magnetic resonance imaging (MRI). [ Time Frame: 5 years ]MRI measures of brain volumes by region of interest, such as hippocampus, will be assessed during the baseline visit and again 3 years later (approximately week 156).
Biospecimen Retention: Samples With DNA
Blood collection for routine laboratory tests (hemoglobin A1c, CBC, BMP 8, lipid panel, TSH, Vitamin B12, insulin, and coagulation). Blood will also be drawn for genotyping and determining ApoE status as well as stored for future assays.
CSF will be collected on a subset of participants and used to analyze amyloid beta, t-tau, p-tau, and stored for future assays.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140865
|Contact: Eric Fischer||(336) 716-6463||E.Fischer@wakehealth.edu|
|United States, North Carolina|
|Wake Forest Baptist Health||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Eric Fischer 336-716-6463 E.Fischer@wakehealth.edu|
|Principal Investigator: Jeff Williamson, MD|
|Principal Investigator:||Jeff Williamson, MD||Wake Forest University Health Sciences|