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Antiretroviral Agent

AntiRetroviral Therapy for Alzheimer's Disease (ART-AD Trial)

San Antonio, TX
Phase 1 & 2
Waitlist Available
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Creatinine clearance test (CrCl) ≥ 50 mL/min
Clinical diagnosis of early Alzheimer's disease (Clinical Dementia Rating (CDR) = 0.5, Mini-Mental State Exam (MMSE) = 24-30)
Must not have
Diagnosis of HIV infection or AIDS (CD4 count < 200), HIV/Hepatitis B Virus (HBV) co-infection, HBV or human T-cell leukemia virus infection
Current use of memantine or sorbitol-containing products
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new drug for Alzheimer's disease to see if it can penetrate the brain, suppress neurodegeneration, and is safe and tolerated by patients.

See full description
Who is the study for?
This trial is for people aged 50-99 with early Alzheimer's (CDR=0.5, MMSE=24-30). They must have stable medication doses if treating Alzheimer's symptoms, normal liver and kidney function tests, controlled cholesterol and glucose levels, no significant psychiatric issues or substance abuse in the past six months, and not be planning to travel during the study.Check my eligibility
What is being tested?
The study is testing a drug called 3TC on patients with early-stage Alzheimer's disease. It aims to see if this drug can target brain changes related to Alzheimer’s, slow down neurodegeneration, enter the central nervous system effectively and determine its safety.See study design
What are the potential side effects?
While specific side effects of 3TC in this context are not listed here, common ones may include digestive issues like nausea or diarrhea; fatigue; headaches; coughing; general body discomforts such as muscle pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidneys are functioning well, with a creatinine clearance rate of 50 mL/min or higher.
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I have been diagnosed with early Alzheimer's disease.
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I am between 50 and 99 years old.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have HIV/AIDS, HBV, or human T-cell leukemia virus.
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I am currently using memantine or products containing sorbitol.
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I do not have brain bleeding, bleeding disorders, or abnormal brain vessels.
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I have not had a stroke, mini-stroke, or unexplained fainting in the last 6 months.
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I have hearing, vision, or movement issues that could affect my trial participation.
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I have had problems with my kidney or liver function.
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I have a condition other than Alzheimer's that could affect my thinking.
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My diabetes is not under control, or I am currently using insulin.
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I have HIV or HBV, or I've used specific HIV medications.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
3TC CNS Penetration
Change in Reverse Transcriptase Activity From Baseline to 24 Weeks in Plasma of Study Participants
Secondary study objectives
Change in Dementia Severity From Baseline to Week 24 of Treatment Based on the PACC-5 Z-score
Incidence of Treatment-Emergent Abnormal Vital Signs
Incidence of Treatment-Emergent Adverse Events

Side effects data

From 2018 Phase 3 trial • 167 Patients • NCT02616783
11%
Nasopharyngitis
8%
Back pain
7%
Diarrhoea
6%
Vitamin D deficiency
6%
Hypertension
5%
Arthralgia
5%
Cough
4%
Bronchitis
4%
Urinary tract infection
1%
Cardiac arrest
1%
Pneumonia
1%
Sepsis
1%
Joint swelling
1%
Colorectal cancer
1%
Hepatocellular carcinoma
1%
Loss of consciousness
1%
Renal colic
1%
Prostatomegaly
1%
Escherichia sepsis
1%
Osteonecrosis
1%
Neuritis cranial
1%
Syncope
1%
Acute coronary syndrome
1%
Cholecystitis acute
1%
Acute kidney injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
E/C/F/TAF
Stay on Baseline Regimen

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-Label 3TCExperimental Treatment1 Intervention
12 subjects will receive 3TC, 300-mg, daily for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3TC
2005
Completed Phase 3
~390

Find a Location

Closest Location:Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases· San Antonio, TX

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
484 Previous Clinical Trials
92,030 Total Patients Enrolled
Owens Medical Research FoundationOTHER
Bess Frost, PhDLead Sponsor

Media Library

3TC (Antiretroviral Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04552795 — Phase 1 & 2
Alzheimer's Disease Research Study Groups: Open-Label 3TC
Alzheimer's Disease Clinical Trial 2023: 3TC Highlights & Side Effects. Trial Name: NCT04552795 — Phase 1 & 2
3TC (Antiretroviral Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04552795 — Phase 1 & 2
~2 spots leftby Mar 2026
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