Clinical trial: Wake Forest Alzheimer's Disease Clinical Core (NCT03140865)

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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.


Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Entailment