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ART-AD

CompletedPhase 1 / PHASE2Results posted

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

Pilot Study to Investigate the Safety and Feasibility of AntiRetroviral Therapy for Alzheimer's Disease (ART-AD)

Lead sponsor

The University of Texas Health Science Center at San Antonio

Asset

Lamivudine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 24-30•Study partner/caregiver required

Primary endpoints

•Reverse Transcriptase Activity•3TC CNS Penetration

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDHSC20200396H

NCT IDNCT04552795

Timeline

Milestones

Study first posted2020-09-17actual

Study start2021-02-15actual

Primary completion2023-05-04actual

Study completion2023-11-04actual

Last update posted2024-08-09actual

Results first posted2024-08-09actual

Assets

Drug assets

Lamivudine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Aged 50-99 years

2. Clinical diagnosis of early Alzheimer's disease (Clinical Dementia Rating (CDR) = 0.5, Mini-Mental State Exam (MMSE) = 24-30)

3. If using drugs to treat symptoms related to Alzheimer's disease, doses must be stable for at least eight weeks prior to screening visit 1

4. Labs: Adequate blood cell counts (white blood cells: 4,000-111,000 cells per microliter (cells/mcL); absolute neutrophil count: 1,800-8,700 cells/mcL; platelets: 120-500 K/µL; hemoglobin 12.0-17.5 grams/dL); LFT's within 2x normal value; creatinine clearance test (CrCl) ≥ 50 mL/min; cholesterol (≤260 mg/dl), triglycerides≤ 400 mg/dl), and glucose control (HbA1c ≤ 8%). Prothrombin time/partial thromboplastin time/international normalized ratio (PT/PTT/INR) within normal limits

5. Body mass index (BMI) within range of 19 - 35 kg/m2

6. Must have a reliable informant or caregiver

7. Participants must have no plans to travel that interfere with study visits

Exclusion criteria

1. Any medical or neurologic condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment

2. Clinically significant unstable psychiatric illness in the past six months

3. Significant hearing, vision, or motor deficits that interfere with participation

4. Alcohol or drug abuse/dependence in the past six months

5. Stroke, transient ischemic attack, or unexplained loss of consciousness in the past six months

6. Unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within the past six months

7. Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities

8. Diagnosis of HIV infection or AIDS (CD4 count < 200), HIV/Hepatitis B Virus (HBV) co-infection, HBV or human T-cell leukemia virus infection

9. History of impaired renal or liver function

10. Current use of memantine or sorbitol-containing products

11. Individuals with HIV, HBV, or who have current/previous use of Nucleoside Reverse Transcriptase Inhibitors (NRTIs) or non-NRTIs.

12. Poorly controlled blood pressure (BP) (systolic BP > 160, diastolic BP > 90 mmHg)

13. Uncontrolled diabetes (HbA1c > 8%, or the current use of insulin)

14. Significant systematic illness or infection in the past 30 days

15. Pregnant women

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Global cognition

Fluid / digital biomarkers

Other (unclassified)

Global cognition

2 endpoints

Secondary/protocol endpoint

Change in Dementia Severity From Baseline to Week 24 of Treatment Based on the PACC-5 Z-score

Time frame:Baseline to 24 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change in Dementia Severity From Baseline to Week 24 of Treatment Based on the PACC-5 Z-score

Time frame:Baseline to 24 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (median), Z-score	Reported bounds
Baselinen=12 Participants	-1.59	--2 - -0.59
POST-Treatmentn=12 Participants	-1.59	--2 - -1.2

Fluid / digital biomarkers

2 endpoints

Primary/protocol endpoint

3TC CNS Penetration

Time frame:24 weeks

ratio, descriptive

Primary/registry result

3TC CNS Penetration

Time frame:24 weeks

ratio, descriptive

Posted result

Group	Value (mean), ng/mL	Reported bounds
Open-Label 3TCn=7 Participants	0.502	-0.0215 - 0.850

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events

Time frame:Baseline to Week 24

event count, event

Secondary/protocol endpoint

Incidence of Treatment-Emergent Abnormal Vital Signs

Time frame:Baseline to Week 24

event count, event

Secondary/registry result

Incidence of Treatment-Emergent Adverse Events

Time frame:Baseline to Week 24

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Open-Label 3TCGastrointestinal bleeding due to peptic ulcern=12 Participants	1	-
No adverse eventsn=12 Participants	11	-

Secondary/registry result

Incidence of Treatment-Emergent Abnormal Vital Signs

Time frame:Baseline to Week 24

event count, event

Posted result

Group	Value (number), Events	Reported bounds
Open-Label 3TCn=12 Participants	0	-

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Change in Reverse Transcriptase Activity From Baseline to 24 Weeks in Plasma of Study Participants

Time frame:Baseline to 24 weeks

change from baseline, improvement

Primary/registry result/low confidence

Change in Reverse Transcriptase Activity From Baseline to 24 Weeks in Plasma of Study Participants

Time frame:Baseline to 24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), Enzyme units	Standard error
Open-Label 3TCn=12 Participants	-0.0074	0.03

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Nicodemus J, Liu CS, Ransom L, Tan V, Romanow W, Jimenez N, Chun J. Sequence Diversity and Encoded Enzymatic Differences of Monocistronic L1 ORF2 mRNA Variants in the Aged Normal and Alzheimer's Disease Brain. J Neurosci. 2025 Jun 18;45(25):e2298242025. doi: 10.1523/JNEUROSCI.2298-24.2025.
PMID40368603via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.