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NCT04552795 · ClinicalTrials.gov registry record · Phase 1
Pilot Study to Investigate the Safety and Feasibility of AntiRetroviral Therapy for Alzheimer's Disease
A Phase 1 study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04552795: Completed Phase 1 study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT04552795 is a Phase 1 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04552795, a Phase 1 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The objective of the study is to evaluate the ability of (-)-L-2',3'-dideoxy-3'-thiacytidine (3TC) to engage its intended target, penetrate the central nervous system (CNS), suppress neurodegeneration, and assess safety and tolerability in patients with early stage Alzheimer's disease. This study will provide the initial data on target engagement and Alzheimer's disease-relevant outcomes for future trials.
Primary Outcome
The extent of 3TC target engagement was measured by calculating the change in reverse transcriptase activity in plasma of participants at baseline compared to week 24 using a modified version of the EnzCheck Reverse Transcriptase (RT) Assay.
Interventions
- DRUG 3TC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2023-11-04 |
| Phase | Phase 1 |
What the finished NCT04552795 record still lists
NCT04552795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which 3TC is the first listed.
NCT04552795 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04552795 about?
NCT04552795 is a clinical study titled "Pilot Study to Investigate the Safety and Feasibility of AntiRetroviral Therapy for Alzheimer's Disease". The objective of the study is to evaluate the ability of (-)-L-2',3'-dideoxy-3'-thiacytidine (3TC) to engage its intended target, penetrate the central nervous system (CNS), suppress neurodegeneration, and assess safety and tolerability in patients with early stage Alzheimer's disease. This study wi...
What is the current status of trial NCT04552795?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2021-02-15. Estimated completion is 2023-11-04.
What interventions are being tested in trial NCT04552795?
The interventions under investigation include: 3TC (DRUG).
Who is sponsoring clinical trial NCT04552795?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04552795's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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