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Pilot Study to Investigate the Safety and Feasibility of AntiRetroviral Therapy for Alzheimer's Disease

NCT04552795 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-08-09

Study results available
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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.

Conditions

  • Alzheimer Disease, Early Onset

Interventions

DRUG

3TC

12 subjects will be administered 3TC, 300mg once daily, via an oral tablet for 24 weeks.

Sponsors & Collaborators

  • Owens Medical Research Foundation

    collaborator OTHER

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Bess Frost, PhD · Univ of Texas Health Science Center at San Antonio

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2023-05-04
Completion
2023-11-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04552795 on ClinicalTrials.gov