Could an HIV drug tame Alzheimer's? a trial puts it to the test

NCT ID NCT07795307

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether a combination of two antiretroviral drugs, emtricitabine and tenofovir, is safe and tolerable in older adults with early Alzheimer's disease. Participants take the drug or a placebo daily for 28 days, then undergo blood tests, cognitive checks, and brain scans over about 3 months. The study measures drug levels and looks for changes in inflammation, aiming to see if targeting dormant viral-like elements in the brain might help.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
emtricitabine and tenofovir disoproxil fumarate combination
What this could lead to
If safe and effective, this could open a new approach to treating Alzheimer's by targeting dormant viral-like elements in the brain.
What could go wrong
This is a small, early-phase safety study, so it may not show clear benefit. The drug combination also carries risks like kidney or bone effects, especially in older adults.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

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