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Can prediabetes predict Alzheimer's? new study seeks answers

NCT ID NCT03140865

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking 850 adults with normal cognition or early memory problems, some of whom have prediabetes. Researchers will monitor memory, brain scans, and spinal fluid over time to see how blood sugar issues might affect Alzheimer's risk. The goal is to better understand the earliest stages of the disease to improve future prevention efforts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help identify early warning signs and risk factors for Alzheimer's, potentially guiding future prevention strategies.
What could go wrong
This is an observational study, not a treatment trial. It may not directly lead to new therapies, and results may take years to yield actionable insights.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 850 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2014

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults, 55 years old and older, who have normal memory, mild memory impairment or AD. All subjects will be in reasonably good health with no significant medical illness that may contribute to memory decline other than MCI or probable AD.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Wake Forest Baptist Health

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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