NCT04552795CompletedPhase 1/2
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)
Source: ClinicalTrials.gov · Last updated 9 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 11 Aug 2020
- Start date
- 15 Feb 2021
- Primary completion date
- 4 May 2023
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Diseases
- Alzheimer disease
- NCT number
- NCT04552795
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 12
- From 15 Feb 2021 to the primary completion date, 4 May 2023
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcohol or drug abuse/dependence in the past six months
- Individuals with HIV, HBV, or who have current/previous use of Nucleoside Reverse Transcriptase Inhibitors (NRTIs) or non-NRTIs.
Other illness
- Any medical or neurologic condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment
- Clinically significant unstable psychiatric illness in the past six months
- Stroke, transient ischemic attack, or unexplained loss of consciousness in the past six months
- Unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within the past six months
- Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
- History of impaired renal or liver function
- Significant systematic illness or infection in the past 30 days
Lab values
- Diagnosis of HIV infection or AIDS (CD4 count \< 200), HIV/Hepatitis B Virus (HBV) co-infection, HBV or human T-cell leukemia virus infection
- Uncontrolled diabetes (HbA1c \> 8%, or the current use of insulin)
Other
- Significant hearing, vision, or motor deficits that interfere with participation
- Current use of memantine or sorbitol-containing products
- Poorly controlled blood pressure (BP) (systolic BP \> 160, diastolic BP \> 90 mmHg)
- Pregnant women
Who the study is looking for
- Aged 50-99 years
- Clinical diagnosis of early Alzheimer's disease (Clinical Dementia Rating (CDR) = 0.5, Mini-Mental State Exam (MMSE) = 24-30)
- 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
- 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
- Body mass index (BMI) within range of 19 - 35 kg/m2
- Must have a reliable informant or caregiver
- Participants must have no plans to travel that interfere with study visits
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sam and Ann Barshop Institute for Longevity & Aging Studies Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.