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Antiretroviral Agent

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

Phase 1 & 2

Waitlist Available

Research Sponsored by Bess Frost, PhD

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 8, week 16, week 24

Awards & highlights

ART-AD Trial 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.

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.

ART-AD Trial 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.

ART-AD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 8, week 16, week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 8, week 16, week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8, week 16, week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

3TC CNS penetration in participants

Change in reverse transcriptase activity from baseline to 24 weeks in blood and cerebrospinal fluid (CSF) of study participants

Secondary outcome measures

Change in dementia severity from baseline to week 24 of treatment based on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB)

Incidence of treatment-emergent abnormal laboratory test results

Incidence of treatment-emergent abnormal vital signs

+1 more

Side effects data

From 2018 Phase 3 trial • 167 Patients • NCT02616783

11%

Nasopharyngitis

Back pain

Diarrhoea

Vitamin D deficiency

Hypertension

Arthralgia

Cough

Bronchitis

Urinary tract infection

Cardiac arrest

Pneumonia

Sepsis

Joint swelling

Colorectal cancer

Hepatocellular carcinoma

Loss of consciousness

Renal colic

Prostatomegaly

Escherichia sepsis

Osteonecrosis

Neuritis cranial

Syncope

Acute coronary syndrome

Cholecystitis acute

Acute kidney injury

100%

80%

60%

40%

20%

Study treatment Arm

E/C/F/TAF

Stay on Baseline Regimen

ART-AD 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

~370

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bess Frost, PhDLead Sponsor

Owens Medical Research FoundationUNKNOWN

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining in this clinical evaluation?

"Clinicaltrials.gov affirms that this clinical trial is open to applicants, having first been posted on February 15th 2021 and last updated April 6th 2022."

Answered by AI

Is this study accepting participants aged eighty or over?

"This medical trial is looking for participants aged between 50 and 80. There are 28 trials for individuals younger than 18, as well as 566 studies open to those older than 65 years-old."

Answered by AI

What is the current enrollment of participants in this clinical trial?

"Indeed, the information on clinicaltrials.gov confirms that this medical trial is recruiting participants. The initial posting date was February 15th 2021 with an update occurring on April 6th 2022. There are 12 openings at three different sites for hopeful candidates to fill."

Answered by AI

Is there a way that I can be part of this clinical endeavor?

"This clinical trial is open to 12 individuals between the ages of 50 and 80 that have been diagnosed with Alzheimer's. In order to be considered, prospective participants must meet certain requirements involving their blood cell counts, lipid levels, creatinine clearance test results, HbA1c score, BMI range, reliable informant or caregiver status and more. Furthermore, they should not plan any trips which would interfere with study visits nor possess a CDR 0.5 or MMSE scores falling within 24-30 points."

Answered by AI

What are the desired outcomes of this investigation?

"The primary endpoints of this trial are the penetration levels of 3TC in participants over an observation period ranging from Baseline to 24 weeks. Secondary considerations include any abnormal vital signs, adverse events caused by the drug being tested and aberrant laboratory test results including a CBC or CMP."

Answered by AI

What else has been explored in regards to the efficacy of 3TC?

"Presently, there are 35 ongoing studies on 3TC with 14 in their final trial stage. Most of these trials originate from Orlando, Florida; however, a total 212 sites across the United States have clinical research looking into this treatment option."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Bess Frost, PhD 2021. "Pilot Study to Investigate the Safety and Feasibility of AntiRetroviral Therapy for Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04552795.

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