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Wake Forest Alzheimer's Disease Clinical Core

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Spinal tap (lumbar puncture)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
  • "This data may include specimen samples such as blood or CSF, cognitive testing data and MRI imaging data."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks for early signs that may predict memory loss and dementia, including problems with blood sugar control. It is for adults with normal memory and thinking, mild thinking problems, or mild Alzheimer's disease. Researchers collect information over time and keep it for future studies.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must fit one of three groups: normal memory and thinking, mild thinking problems, or mild Alzheimer's disease.
  • Normal thinking group: You report no thinking problems, and expert-reviewed tests show no impairment.
  • Normal thinking group: Your Clinical Dementia Rating (CDR), a measure of thinking and daily skills, must be 0 or 0.5. Your blood sugar must be below 140 mg/dL two hours after a glucose test.
  • Normal thinking group: A reliable study partner must attend at least the first visit.
  • Mild thinking problems group: Tests must show problems with memory or skills such as planning. Your CDR must be 0 or 0.5, and you must have a reliable study partner.
  • Alzheimer's group: Experts must confirm probable mild Alzheimer's disease. Alzheimer's with blood vessel damage may qualify if there has been no stroke in an area served by a large blood vessel.
  • Alzheimer's group: Your Mini-Mental Status Exam, a thinking test, must score at least 10. Your CDR must be at least 0.5. Blood sugar must be normal or in the prediabetes range, meaning higher than normal but below diabetes levels.
  • Alzheimer's group: A reliable study partner must attend all visits.

Who can't join

  • Important abnormal lab results, or another brain or nerve disease that could affect thinking, such as stroke, Parkinson's disease, multiple sclerosis, or a serious head injury.
  • Serious illness or organ failure, such as severe uncontrolled heart disease, lung disease needing oxygen, severe liver or kidney disease, active cancer, or an illness expected to limit life to under 3 years. Study doctors may exclude other serious conditions.
  • Current drug or alcohol misuse, more than 14 alcoholic drinks a week, or a history of alcohol or drug misuse in the past 10 years.
  • Poorly controlled depression or another mental health illness, as judged by study staff.
  • Current use of insulin, antipsychotic drugs, strongly anticholinergic drugs, or sedatives. Benzodiazepines are allowed only as needed fewer than 3 times a week. Blood thinners are not allowed for people having a spinal tap.
  • Use of seizure medicine for a seizure disorder. Use for other illnesses will be reviewed by the study doctor.
  • For MRI scans: unsafe implants or metal, such as certain heart devices or metal in the eyes. For any brain imaging: being unable to lie on the scanner bed for 40 minutes or having fear of enclosed spaces.
  • For ADCC-BIG: severe obesity or a lower back problem that could prevent a successful spinal tap to collect fluid around the brain and spinal cord.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NC