Alzheimer's Disease Trial, Recruiting NCT03140865 Sponsor: Wake Forest University Health Sciences Condition: Alzheimer's Disease
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Alzheimer's Disease Trial, Recruiting

NCT03140865
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Group 1 – People with normal cognition:

  • People who have no concerns about their own memory or thinking ability
  • People who show no signs of cognitive problems on formal testing, as reviewed by an expert panel
  • People with a Clinical Dementia Rating (CDR) score of 0 or 0.5 (a standard measure of memory and thinking; confirm with trial site)
  • People whose blood sugar response to a sugar-drink test falls within the normal range (below 140 mg/dL at 2 hours), according to standard guidelines
  • People who have a trusted family member, friend, or carer available to attend at least the first study visit with them

Group 2 – People with Mild Cognitive Impairment (MCI):

  • People who show measurable memory and/or problem-solving difficulties on formal testing
  • People with a CDR score of 0 or 0.5
  • People who have a trusted family member, friend, or carer who can attend study visits with them

Group 3 – People with Alzheimer's Disease (AD):

  • People who have been diagnosed with mild Alzheimer's disease, or a combination of Alzheimer's and blood vessel-related brain changes (without a large stroke), confirmed by an expert panel
  • People with a score of 10 or above on a standard memory and thinking test (MMSE), and a CDR score of 0.5 or higher
  • People whose blood sugar levels are in the normal range or in the pre-diabetes range
  • People who have a trusted family member, friend, or carer available to attend all study visits

Who may not be able to join:

  • People with significantly abnormal blood test results
  • People with a serious neurological condition affecting thinking (other than Alzheimer's disease), such as stroke, Parkinson's disease, multiple sclerosis, or a severe head injury with more than 30 minutes of unconsciousness in the past year, or lasting brain damage from an injury
  • People with a serious medical illness or major organ failure, including severe uncontrolled heart disease, lung disease requiring oxygen, severe liver disease, advanced kidney disease or near-dialysis, active cancer, or any life-limiting condition with a life expectancy of less than 3 years
  • People currently misusing substances or alcohol, defined as drinking more than 14 alcoholic drinks per week, or people with a history of alcoholism or substance misuse within the past 10 years
  • People with poorly controlled depression or another psychiatric condition, as assessed by the study team
  • People currently taking certain medications, including anti-psychotics, benzodiazepines (taken more than 3 times per week), blood thinners (for those having a lumbar puncture), or strongly sedating or anticholinergic medicines
  • People taking anti-seizure medication for a diagnosed seizure disorder (use for other conditions will be reviewed individually by the study doctor)
  • People currently using insulin
  • People who are unable to have a brain MRI scan, including those with pacemakers, aneurysm clips, artificial heart valves, ear implants, or metal objects in the eyes
  • People who are unable to lie still in a scanner for 40 minutes, or who experience claustrophobia (for those completing brain imaging)
  • People with significant obesity or a lower back condition likely to make spinal fluid collection difficult, as assessed by the study doctor (for a specific sub-study)
  • People with other significant medical conditions, at the discretion of the research team

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Jeff Williamson, MD, Wake Forest University Health Sciences

Phone: (336) 716-6317

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 January 2014
Est. completion
1 January 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in performance on cognitive measures.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov