NCT03140865 Wake Forest Alzheimer's Disease Clinical Core

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 850 participants in total. It began in 2014-01 with a primary completion date of 2030-01.

Brief 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.

Eligibility Criteria

Inclusion Criteria: Group 1: Cognitively Normal (CN) 1. No subjective complaints of cognitive impairment 2. No cognitive impairment evident on formal testing interpreted by expert adjudication committee (typically, performance not worse than 1 SD below demographically relevant norms) 3. Clinical Dementia Rating (CDR) = 0 or 0.5 4. Normal glycemic control as indicated by American Diabetes Association (ADA) guidelines for normal 2 hour glycemic response to a glucose tolerance test (\< 140 mg/dL). 5. Reliable collateral or study partner available to attend Visit 1 at a minimum Group 2: Mild Cognitive Impairment (MCI) 1. Objective evidence of memory and/or executive function deficits on neuropsychological testing (typically 1.5 SD below demographically relevant norms) 2. CDR = 0 or 0.5 3. Reliable collateral or study partner Group 3: Alzheimer's Disease (AD) 1. Diagnosis of probable mild AD, diagnosed with NIA-AA criteria, or mixed AD and vascular pathology as long as there is not a large vessel territory stroke, adjudicated by expert consensus panel. 2. Mini-Mental Status Exam (MMSE) score ≥ 10; CDR = ≥0.5 3. Normal glycemic control or prediabetes 4. Reliable collateral or study partner available to attend all visits Exclusion Criteria: 1. Clinically significant abnormal labs 2. Significant neurologic disease that might affect cognition, other than AD, such as stroke, Parkinson's disease, multiple sclerosis, or recent severe head injury with loss of consciousness for more than 30 minutes within the last year, or with permanent neurologic sequelae 3. Clinically significant medical illness or organ failure as determined by study clinicians, including severe, uncontrolled cardiovascular disease, oxygen-treated chronic obstructive pulmonary disease, severe liver disease, Stage 4 chronic kidney disease or impending dialysis, active cancer, or other life-limiting condition with life expectancy less than 3 years 4. Current substance abuse or heavy alcohol consumption defined as \>14 alcoholic drinks per week; or history of alcoholism or substance abuse within previous 10 years 5. Current poorly controlled depression or other psychiatric illness as determined by clinical judgement of study clinicians or neuropsychologists 6. Current use of anti-psychotic, benzodiazepines (PRN use \<3 times per week is acceptable), anti-coagulants (for participants who will receive a lumbar puncture), strongly anticholinergic or sedative medications 7. Use of anticonvulsant for seizure disorder. (Use of anticonvulsant to treat other illnesses will be reviewed by the study MD and eligibility will be determined on a case by case basis.) 8. Current use of insulin 9. Brain MRI contraindications; including use of pacemakers, aneurysm clips, artificial heart valves, ear implants or metal/foreign objects in the eyes will be excluded from MRI 10. For participants completing any brain imaging protocol, inability to lie on the scanner bed for 40 minutes, or claustrophobia 11. For ADCC-BIG, significant obesity or a lower back condition that is likely to impede successful collection of CSF, as determined by study physician judgment 12. Other significant medical conditions at the investigators' discretion

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