Repurposing a Combination Antiretroviral Drug Therapy to Target Retrotransposons and Treat Early Alzheimer's Disease - Alzheimer’s Disease & Related Dementias Atlas

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID2026P002048

NCT IDNCT07795307

Secondary IDUG3AG104643NIH, award pending

Timeline

Milestones

Study first posted2026-08-31actual

Last update posted2026-08-31actual

Study start2026-12estimated (month precision)

Primary completion2028-07estimated (month precision)

Study completion2028-09estimated (month precision)

Assets

Drug assets

Emtricitabine and tenofovir disoproxil fumarate combination

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

14

Other (unclassified)

3

Safety / tolerability / PK

14 endpoints

Primary/protocol endpoint

Safety and tolerability

Time frame:28 days

event count, event

Primary/protocol endpoint

Safety and tolerability

Time frame:28 days

descriptive

Primary/protocol endpoint

Safety and tolerability

Time frame:28 days

event count, event

Primary/protocol endpoint

Safety and tolerability

Time frame:28 days

descriptive

Primary/protocol endpoint

Safety and tolerability

Time frame:28 days

descriptive

Primary/protocol endpoint

Safety and tolerability

Time frame:28 days

change from baseline, event

Primary/protocol endpoint

Safety and tolerability

Time frame:28 days

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) Concentration average

Time frame:28 days

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) Concentration maximum

Time frame:28 days

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) T max

Time frame:28 days

time to event, event

Secondary/protocol endpoint

Pharmacokinetics (PK) lambda z

Time frame:28 days

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) AUC last

Time frame:28 days

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) AUC 24 hours

Time frame:28 days

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) T 1/2

Time frame:28 days

concentration, descriptive

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Pharmacodynamics (PD)

Time frame:28 days

concentration, descriptive

Secondary/protocol endpoint/low confidence

Activity of reverse transcriptase

Time frame:28 days

descriptive

Secondary/protocol endpoint/low confidence

Markers of systemic inflammation

Time frame:28 days

descriptive

Publications (10)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.