Alzheimer's Disease Trial, Recruiting NCT04124029 Sponsor: VA Office of Research and Development Condition: Alzheimer's Disease
Back to Alzheimers Disease

Alzheimer's Disease Trial, Recruiting

NCT04124029
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:

  • People who have normal color vision and can see clearly (vision of 20/30 or better)
  • People who are able to put in genuine effort during memory testing (as measured by a specific effort test called the TOMM)
  • People who have the ability to make their own decisions about participating
  • People who are medically suitable for a lumbar puncture (spinal tap), meaning they are not on blood-thinning medications (including aspirin or Plavix), have no infection near the lower spine, have normal blood clotting levels (INR below 1.4 and platelet count above 50,000), and have no abnormal growths or lesions shown on a brain scan (MRI)
  • People with mild traumatic brain injury (TBI): Those who have a doctor's diagnosis of one or more mild TBI episodes, which involves loss of consciousness, memory loss after the injury, and/or a period of confusion
  • People with moderate TBI: Those who have a doctor's diagnosis of one or more moderate TBI episodes involving loss of consciousness lasting more than 30 minutes, memory loss after the injury lasting more than 24 hours, and a period of confusion lasting more than 24 hours
  • People with Mild Cognitive Impairment (MCI): Those who meet the standard medical criteria for MCI (without any history of TBI), as determined by a specialist neurologist — meaning they show some decline in thinking or memory on testing but are still able to manage daily life independently, and whose memory test scores are matched with older TBI participants in the study
  • Healthy controls: People with no history of TBI and normal thinking and memory test results, matched by age, education, and sex with mild TBI participants in the study
  • The trial welcomes participants regardless of gender, race, ethnicity, or socioeconomic background

Who may not be able to join:

  • People whose primary language is not English
  • People who are unable to understand or engage with the consent process
  • People with a history of a TBI within the past year (at the time of the study)
  • People who are currently experiencing thoughts of harming themselves or others that require clinical intervention
  • People who have a diagnosis of schizophrenia or bipolar disorder
  • People who are currently struggling with alcohol or drug misuse
  • People who have a significant neurological condition other than those specifically listed in the inclusion criteria
  • People whose decision-making ability is impaired
  • People who are unable to have an MRI scan due to having metal implants, shrapnel, aneurysm clips, or a pacemaker in their body
  • People who are pregnant
  • People in the non-TBI groups (MCI or healthy controls) who have a history of TBI
  • People who have a medical reason that prevents them from safely having a lumbar puncture or blood draw, including use of blood-thinning medications (such as aspirin or Plavix) or an abnormal growth shown on an MRI scan

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 28 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: Katherine Turk, MD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Phone: (857) 364-2139

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 July 2021
Est. completion
30 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To better understand the contribution of mild Traumatic Brain Injury (mTBI) to neurodegeneration with the intent of detecting early behavioral, physiologic, anatomic, and protein evidence of neurodegeneration due to AD and CTE

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: 28 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