Wake Forest Alzheimer's Disease Clinical Core — ADCC  

Mild Cognitive Impairment Clinical Trial

Official title: Wake Forest Alzheimer's Disease Clinical Core

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Prediabetic State

• NCT number: NCT03140865
• Study type: Observational [Patient Registry]
• Source: Wake Forest University Health Sciences
• Contact: Sarah Bohlman, MSL
• Phone: 336-716-7354
• Email: sarabrow@wakehealth.edu
• Status: Recruiting
• Start date: January 2014
• Completion date: January 2031