NCT05446584 Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History
| NCT ID | NCT05446584 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2023-04-20 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 75 participants in total. It began in 2023-04-20 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will probe if the biological changes in amnestic mild cognitive impairment (aMCI) are related to a history of mild traumatic brain injury (mTBI) using high definition transcranial direct current stimulation (HD-tDCS) and blood-derived biomarker tools. Participants who Do as well as those who Do Not have a history of mTBI will be enrolled in the study.
Eligibility Criteria
Inclusion Criteria: 1. Active diagnosis of amnestic mild cognitive impairment 2. Presence of an mTBI history for the mTBI+ group; absence of an mTBI history for a control sample 3. Female and male subjects 4. All races/ethnicities 5. Age 55 years and older 6. Fluent in English Exclusion Criteria: 1. Mild traumatic brain injury within past year 2. Lifetime history of moderate or severe brain injury 3. Lifetime major neurologic syndromes (e.g., stroke, epilepsy, brain tumor) 4. Lifetime major cardiovascular conditions (e.g., heart attack, heart failure) 5. Current substance use disorder 6. Current major psychiatric disorders (e.g., major depressive disorder, bipolar disorder) 7. Current vision or hearing impairment that interferes with testing 8. Any electronic and or metallic implants in the skull or brain 9. Current medication use known to alter HD-tDCS reactivity
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05446584 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05446584 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05446584 currently recruiting?
Yes, NCT05446584 is actively recruiting participants. Contact the research team at Hannah.Cabrera@utsw.edu for enrollment information.
Where is the NCT05446584 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT05446584 clinical trial?
NCT05446584 is sponsored by University of Texas Southwestern Medical Center. The trial plans to enroll 75 participants.