Wake Forest Alzheimer's Disease Clinical Core

Plain English Summary

Wake Forest Alzheimer's Disease Clinical Core is a Not Applicable clinical trial sponsored by Wake Forest University Health Sciences studying Alzheimer's Disease, Mild Cognitive Impairment, Prediabetic State. This study is looking for ways to understand how early changes in the brain and body's sugar processing might lead to Alzheimer's disease. It's for adults who are either healthy, have very early memory concerns (mild cognitive impairment), or have been diagnosed with early Alzheimer's disease. Participants will undergo regular cognitive tests, blood tests, and possibly brain scans or spinal fluid tests over several years. Currently, there are no cures for Alzheimer's, but this study aims to find better ways to identify and potentially intervene in the disease process much earlier. The trial aims to enroll 850 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You may be able to join if you have no memory concerns, have mild memory problems, or have been diagnosed with early Alzheimer's disease. Participants must have normal or pre-diabetic blood sugar levels (unless you have early Alzheimer's, where normal levels are required). You cannot join if you have other significant neurological diseases (like stroke or Parkinson's), severe uncontrolled medical conditions, current substance abuse, or certain psychiatric conditions. Specific medical conditions, use of certain medications (like sedatives or anti-coagulants if undergoing spinal tap), and contraindications for MRI scans will also exclude you. This trial is studying Alzheimer's Disease, Mild Cognitive Impairment, Prediabetic State, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The study will track how well participants perform on thinking and memory tests over five years to see if early metabolic changes are linked to cognitive decline. The specific primary outcome measures are: Change in performance on cognitive measures. (5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is important because it investigates how metabolic issues, like problems with sugar processing, might be an early trigger for Alzheimer's, offering a new angle for prevention and treatment This research targets Alzheimer's Disease, Mild Cognitive Impairment, Prediabetic State, where improved treatment options are needed.

Investor Insight

This observational study by a major academic institution focuses on early Alzheimer's and metabolic health, a growing area of interest for pharmaceutical companies developing treatments for neurodegen The large enrollment target of 850 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if your current health conditions and medications make you a good candidate for this study. Be prepared for regular visits over five years, which will involve cognitive assessments, blood draws, and potentially other medical tests. You'll need to have a reliable friend or family member who can accompany you to some appointments. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 850 participants

Primary Outcomes

• Change in performance on cognitive measures. (5 years)

Secondary Outcomes

• Change in biomarker levels in cerebrospinal fluid (CSF). (5 years)
• Change in brain volumes on magnetic resonance imaging (MRI). (5 years)

Full 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

Trial Locations

• Wake Forest Baptist Health, Winston-Salem, North Carolina, United States

Frequently Asked Questions

Related Conditions

• Alzheimer's Disease
• Mild Cognitive Impairment
• Prediabetic State
• Dementia
• Cognitive Decline
• Neurodegenerative Diseases
• Metabolic Syndrome
• Diabetes Mellitus
• Vascular Dementia
• Aging

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