Actively Recruiting

Age: 55Years +
All Genders
Healthy Volunteers
NCT03140865

Wake Forest Alzheimer's Disease Clinical Core

Led by Wake Forest University Health Sciences · Updated on 2026-03-27

850

Participants Needed

1

Research Sites

887 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Wake Forest Alzheimer's Disease Clinical Core

Who Can Participate

Age: 55Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 55 years and older
  • Cognitively normal participants have no subjective cognitive complaints and normal cognitive test results
  • Mild cognitive impairment participants have objective memory or executive function deficits and Clinical Dementia Rating (CDR) of 0 or 0.5
  • Alzheimer's Disease participants diagnosed with probable mild AD or mixed AD/vascular pathology with MMSE score of at least 10 and CDR of 0.5 or less
  • Normal or prediabetic glycemic control according to ADA guidelines
  • Reliable collateral or study partner available to attend visits
Not Eligible

You will not qualify if you...

  • Clinically significant abnormal laboratory test results
  • Significant neurological diseases other than AD, such as stroke, Parkinson's disease, multiple sclerosis, or recent severe head injury with prolonged loss of consciousness or lasting effects
  • Severe medical illnesses or organ failure including uncontrolled cardiovascular disease, oxygen-dependent COPD, severe liver disease, advanced kidney disease, active cancer, or life expectancy under 3 years
  • Current substance abuse or heavy alcohol use (>14 drinks per week) or history within 10 years
  • Poorly controlled depression or other psychiatric illness as determined by clinicians
  • Use of antipsychotic, benzodiazepines (except occasional use), anticoagulants (for lumbar puncture participants), or strongly sedative medications
  • Use of anticonvulsants for seizure disorders (other uses reviewed case-by-case)
  • Current use of insulin
  • Contraindications to brain MRI including pacemakers, aneurysm clips, artificial heart valves, ear implants, or metal in eyes
  • Inability to lie still in MRI scanner for 40 minutes or claustrophobia
  • For biomarker-intensive group, significant obesity or lower back problems preventing safe cerebrospinal fluid collection
  • Other significant medical conditions at investigators' discretion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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Research Team

L

Lauren Latham

CONTACT

K

Karen Gagnon

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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