Observational study on Alzheimer's disease and cognitive impairment
Wake Forest Alzheimer's Disease Clinical Core
This study is trying to gather important information and samples from adults aged 55 and older, with or without memory problems, to help improve early detection and treatment of Alzheimer's disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 850 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT03140865 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a comprehensive data and specimen repository for Alzheimer's disease, focusing on adults aged 55 and older, with or without cognitive deficits. It will catalog cognitive data, human specimen samples, medical history, and neuroimaging data to facilitate collaboration across Alzheimer's Disease Centers in the U.S. The goal is to enhance early detection and develop new treatment strategies by sharing standardized outcomes and optimizing data acquisition. Participants may also have the option to engage in a biomarker-intensive substudy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 55 and older, both cognitively normal and those with mild cognitive impairment or Alzheimer's disease.
Not a fit: Patients with severe cognitive impairment or those under 55 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and innovative treatment strategies for Alzheimer's disease and related cognitive impairments.
How similar studies have performed: Other studies focusing on early detection and metabolic dysfunction in Alzheimer's have shown promise, indicating that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Baptist Health — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jeff Williamson, MD — Wake Forest University Health Sciences
- Study coordinator: Lauren Latham
- Email: lauren.latham@advocatehealth.org
- Phone: (336) 716-6317
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.