Overview

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

Status:
Recruiting

Trial end date:
2022-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Bess Frost, PhD

Collaborator:

Owens Medical Research Foundation

Treatments:

Lamivudine

Criteria

Inclusion Criteria:

1. Aged 50-80 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