Repurposing a Combination Antiretroviral Drug Therapy to Target Retrotransposons and Treat Early Alzheimer's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 55 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 10 visits
- Time periods mentioned: 4 weeks, 28 days, 3 months, 45 days
- Procedures mentioned: Blood draws, Physical exams, Heart tracing (ECG), Questionnaires, Pills
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The goal of this clinical trial is to determine the safety, tolerability, drug levels and biological effects of two doses of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) combination administered daily for 4 weeks in older adults with early Alzheimer's disease."
- "Participants will: * Take FTC-TDF combination or a placebo every day for 28 days. * Have 10 clinic visits over approximately 3 months. * Undergo blood tests, physical exams, cognitive testing, and scans of their brain."
- "Objectives: To conduct a phase 1b trial to determine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple ascending doses of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) combination administered daily for 4 weeks in older adults with early Alzheimer's disease (AD)."
- "Additionally, we will perform safety laboratory tests including blood counts and chemistries, coagulation profile, physical exams, vital signs, and electrocardiogram (ECG)."
- "The participants will take the study drug orally once daily for 28 days."
- "Questionnaires will be administered at screening (Clinical Dementia Rating \[CDR\], Mini-Mental State Exam \[MMSE\], Logical Memory, 15-item Geriatric Depression Scale \[GDS\], and Columbia-Suicide Severity Rating Scale \[C-SSRS\]), which will last up to 45 days."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests two doses of emtricitabine and tenofovir disoproxil fumarate (FTC-TDF) in older adults with early Alzheimer's disease. Researchers will compare the drug with a placebo, a look-alike with no drug, to check safety, drug levels, and effects on the body and inflammation. Participants take pills daily for 28 days and have 10 clinic visits over about 3 months.
The goal of this clinical trial is to determine the safety, tolerability, drug levels and biological effects of two doses of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) combination administered daily for 4 weeks in older adults with early Alzheimer's disease. The main questions it aims to answer are: * Is FTC-TDF combination safe in older adults who have early Alzheimer's disease. * To measure the FTC-TDF levels at different times. * To measure the biological effects of FTC-TDF combination. * To measure the effects of FTC-TDF combination on inflammation. Researchers will compare two doses of FTC-TDF combination to a placebo (a look-alike substance that contains no drug) to see if FTC-TDF combination is safe in older adults who have early Alzheimer's disease. Participants will: * Take FTC-TDF combination or a placebo every day for 28 days. * Have 10 clinic visits over approximately 3 months. * Undergo blood tests, physical exams, cognitive testing, and scans of their brain.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have a diagnosis of mild cognitive impairment (problems with memory or thinking) or Alzheimer's dementia.
- Have blood test signs of Alzheimer's disease. A spinal fluid test or brain scan from the past 2 years may also qualify with study team approval.
- Have a Clinical Dementia Rating score of 0.5 or 1 and a Mini-Mental State Exam score of 18–30. These tests measure memory, thinking, and daily function.
- Have a score below 6 on the 15-question depression scale and meet the memory test cutoff for your years of schooling.
- If taking Alzheimer's medicines, have stable treatment for at least 8 weeks before screening for cholinesterase inhibitors or memantine, or 6 months for lecanemab or donanemab.
- Be able to see and hear well enough to complete study tests.
- Have a study partner who knows you well and has regular contact with you.
- Be willing and able to complete all study tests in English and give written consent.
Who can't join
- Have certain brain or nerve diseases other than Alzheimer's, lasting problems after a serious head injury, or major brain changes. Brain scans showing certain strokes, bleeding larger than 1 cm, or severe small blood vessel disease also exclude you.
- Have an alcohol or drug use disorder within the past 2 years; untreated major depression within the past year; bipolar disorder; schizophrenia; or current major problems with behavior or losing touch with reality.
- Have an illness or unstable health condition that could affect study tests, or any condition the study doctor thinks could make participation unsafe or affect results.
- Take antipsychotic medicines or antidepressants with anticholinergic effects, such as dry mouth or constipation. The study requires at least 8 weeks off medicines that affect mood or thinking before screening.
- Have liver enzyme levels over 3 times the normal limit, a kidney filtering rate below 60 mL/min, or an HbA1c blood sugar level above 8.5%.
- Have been in another trial of an experimental treatment within 3 months, or within 5 half-lives of that treatment, whichever is shorter. A half-life is the time it takes for half a drug to leave the body.
- Test positive for hepatitis B surface antigen, a sign of hepatitis B infection, or have a history of osteoporosis (weak bones) or osteomalacia (soft bones).
- Take FTC-TDF to prevent or treat HIV.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Meets National Institute on Aging-Alzheimer's Association clinical diagnostic criteria for mild cognitive impairment (MCI) or AD dementia. * Has evidence of AD assessed by plasma p-tau217. Prior cerebrospinal fluid (CSF) or positron emission tomography (PET) amyloid testing (obtained clinically or through previous research) from the past 2 years may be used for eligibility with approval from study investigators. * Clinical Dementia Rating (CDR) global score of 0.5 or 1. * Mini-Mental State Exam (MMSE) score of 18 to 30 (inclusive). * 15-item Geriatric Depression Scale (GDS) score of \< 6. * Impaired memory performance below an education adjusted cut-off score on the Logical Memory II subscale delayed paragraph recall of Wechsler Memory Scale-Revised (WMS-R) (≥16 years: ≤8; 8-15 years: ≤4; 0-7 years: ≤2). * May take FDA approved medications for the treatment of AD dementia, but if taking such medications, they must be stable for at least 8 weeks before screening (for cholinesterase inhibitors and/or memantine) or 6 months (for lecanemab or donanemab). * Has adequate visual and auditory acuity to participate in neuropsychological testing and other study outcomes. * Has availability of a study partner who has regular contact with the participant and knows him/her well. * Is willing and able to participate in all assessments in English. * Is capable of providing written informed consent Exclusion Criteria: * Neurologic diseases: Neurologic disease other than AD such as Parkinson's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, normal pressure hydrocephalus, corticobasal syndrome, malignant brain tumor (within the last 1 year), multiple sclerosis, or significant head trauma (e.g. with loss of consciousness for 30 minutes or more) followed by persistent neurologic deficits, or significant structural brain abnormalities. * Neuroimaging: Magnetic resonance imaging (MRI) scan evidence of cortical stroke or macrohemorrhage (\>1 cm), strategically located lacunar stroke, or severe small vessel disease. * Alcohol or substance use disorder or dependence (Diagnostic and Statistical Manual of Mental Disorders version 5 \[DSM 5\] criteria) within the last 2 years. * Untreated major depressive disorder (within the last 1 year), bipolar disorder, schizophrenia (DSM 5 criteria), or current major psychotic symptoms or behavioral problems. * Any systemic illness or unstable medical conditions, which could affect valid cognitive and self-report assessments. * Excluded medications: Antipsychotic medications; antidepressant medications with anticholinergic side effects. Washout from psychoactive medications for at least 8 weeks before screening. * Laboratory abnormalities: AST or ALT \> 3 times the upper limit of normal; creatinine clearance \<60 mL/min; HbA1C \> 8.5%. * Participation in an investigational trial within the past 3 months or 5 half-lives, whichever is shorter * Conditions which, in the opinion of the investigator, would jeopardize safety or impact the validity of the study results. * Person who is positive for HBV Surface Antigen. * Person with a history of osteoporosis or osteomalacia. * Person taking FTC-TDF for pre-exposure prophylaxis or treatment of HIV.
Study sites (1)
MA
- Brigham and Women's Hospital · Boston, MA 02115Danielle M Lavey · Study contact · 617-732-8085 · dlavey@bwh.harvard.eduMore trials in Boston