Mild Cognitive ImpairmentPhase 2NCT06519357
A Single-center, Self-controlled, Prospective Case Series Pilot Study to Assess the Effect of Lamivudine (3TC) on Neurocognitive Impairment Biomarkers and Type-I IFN (Interferon)-Stimulated Genes in the Plasma of Patients With Mild Cognitive Impairment (MCI)
A Phase 2 study testing Lamivudine 300 MG in people with Mild Cognitive Impairment, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.
Trial summary
To assess the ability of lamivudine to lower the levels of neurocognitive impairment biomarkers in the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period. To assess the incidence, nature, and severity of Treatment Emergent Adverse Events (TEAE). Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Lamivudine 300 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 28 Oct 2024to Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants 55 to 90 years of age (both inclusive) at the time of signing the informed consent.
- Diagnosis of prodromal AD: MCI due to AD according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria as determined by a neurologist, geriatrician, psychiatrist, or clinician approved by the Sponsor or designee.
- Clinical Dementia Rating (CDR)-Global Score of 0.5
- Imaging studies (MRI or CT) within 21 years prior to screening that exclude secondary causes of dementia.
- that has findings consistent with AD and without any other disease that may cause dementia.
- Documented confirmation of AD diagnosis by positive CSF AD signature or positive amyloid-PET AD signature. Amyloid positivityCSF AD positivity established with low levels of CSF Aβ1-42 or CSF Aβ1-42/Aβ1-40 and high levels of p-Tau. A CSF examination performed within 612 months prior to screening are is allowed. A positive amyloide-PET is defined as abnormal deposits of amyloid in the PET imaging. Subjects without documented positive AD biomarker status must have a positive CSF biomarker result from a sample provided at screening.
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- If receiving an approved medication for AD (i.e., donepezil, galantamine, rivastigmine, memantine, or memantine/donepezil combination product), must be on the medication with a stable dose for at least 4 weeks before the screening visit (dosing should remain stable throughout the study).
- If receiving an OTC supplement for cognition (e.g., gingko biloba, omega-3 polyunsaturated fatty acid, vitamin E, curcumin), must not be exceeding the recommended dose and be at stable dose for at least 4 weeks prior to screening visit.
- Able to visit the study center and undergo cognitive, functional, and other tests specified in the protocol.
- Has a caregiver who:
- Agrees to accompany the participant to all study visits and able to supervise the participant's compliance with the study procedures and provide detailed information about the participant.
- Either lives with the participant or sees the participant on average for ≥ 1 hour/day ≥ 3 days/week, or in the Investigator's opinion, the extent of contact is sufficient to provide meaningful assessment of changes in participant behavior and function over time and provide information on safety and tolerability.
- Can read, understand, and speak the designated language at the study center.
- Caregiver must be cognitively able to fulfill the requirements of the study.
- A male participant must agree to use a highly effective contraception method during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to use a highly effective contraception method during the treatment period and for at least 3 months after the last dose of study treatment.
- A WOCBP must have a negative serum pregnancy test at screening and must use medically accepted means of contraception throughout the study.
- Written informed consent provided by participant (or legal representative) and caregiver prior to any study-specific procedures.
Who cannot join
- Any other cause of dementia shown by MRI or CT findings within 2 years of screening and neurological examination at screening.
- Possible, probable, or definite vascular dementia according to the National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences (NINDS-AIREN) criteria.
- Evidence of significant abnormality that would suggest another potential etiology for dementia (e.g., evidence of cerebral contusion, encephalomalacia, aneurysm, vascular malformation, > 10 microhemorrhages, macrohemorrhage, single infarct > 1 cm3).
- Other central nervous system diseases that may cause cognitive impairment (e.g., cerebrovascular disease including cerebrovascular dementia, Parkinsonism, Huntington's disease, subdural hematoma, normal pressure hydrocephalus, brain tumor, Creutzfeldt-Jakob disease).
- Concurrent or history of clinically significant psychiatric conditions (e.g., schizophrenia or bipolar affective disorder) that in the Investigator's opinion prevents the participant from participating or is likely to confound interpretation of drug effect or affect cognitive assessments.
- Vitamin B12, folic acid, syphilis serology, and thyroid stimulating hormone (TSH) results that are thought to contribute to the severity of dementia or cause dementia. Participants may be enrolled if in the Investigator's medical judgment, the abnormal laboratory values are not the cause of the cognitive symptoms.
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- History of known or suspected seizures including febrile seizures (excluding self-limited childhood febrile seizures), a history of significant head trauma with loss of consciousness or recent unconsciousness that is not explained.
- Acute or unstable cardiovascular disease, active peptic ulcer, uncontrolled hypertension, uncontrolled diabetes or any medical condition that may interfere with the completion of the clinical study.
- Known allergies, hypersensitivity, or intolerance to lamivudine or similar products or excipients.
- History of alcohol, substance abuse or dependence as per DSM-V criteria (except nicotine dependence) within the last 3 years.
- Concurrent malignancies or invasive cancers diagnosed within the past 3 years except for non-metastatic basal cell carcinoma or squamous cell carcinoma of skin, in situ carcinoma of the uterine cervix or non-metastatic prostate cancer.
- Sexually active WOCBP or man capable of fathering a child who do not consent to using medicinally acceptable contraception (such as surgical sterilization, intrauterine contraceptive device, condom, or diaphragm, an injectable or inserted contraceptive) during the study and for 3 months after the last dose of study treatment.
- Use of anxiolytics, narcotics, or sleep aids in a manner that would interfere with cognitive testing, in the opinion of the investigator. Atypical antipsychotics may be used at the discretion of the Investigator. Tricyclic antidepressants and monoamine oxidase (MAO) inhibitors may be used at the discretion of the investigator.
- Previous treatment with lamivudine.
- Received an investigational product for AD within the last 3 months.
- Participated in another clinical study within 4 weeks prior to this study.
- Subject has any of the following laboratory findings at screening:
- Severe liver dysfunction (Alanine aminotransferase > 2x upper limit of normal (ULN), aspartate aminotransferase > 2x ULN, or history of clinically significant liver disease in the investigator's judgment.
- Hemoglobin ≤ 10 g/dl.
- International Normalized Ratio (INR) > 1.5 or total bilirubin > 1.5 x ULN (unless subject has evidence of Gilbert's disease).
- Renal impairment Creatinine clearance (CrCl) < 45 ml/min.
- Poorly controlled diabetes as defined by hemoglobin A1C (HbA1C) > 8.
- Positive blood screen for Human Immunodeficiency Virus (HIV-1 and 2), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus antibodies (HCV-Ab) at Screening.
- Body weight ≤ 35 kg.
- Resides in a moderate to high dependency continuous care facility (residence in low grade assisted living facility where there is sufficient autonomy to permit valid evaluation of activities of daily living is allowed).
- Any other reason that in the opinion of the investigator would make the participant ineligible to participate or to complete this study.
- Refrain from donating blood or blood products from the screening visit until 3 months after the EOS/ET visit.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the ability of lamivudine to lower the levels of neurocognitive impairment biomarkers in the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period.
To assess the incidence, nature, and severity of Treatment Emergent Adverse Events (TEAE).
Read the detailed description
To assess the ability of lamivudine to lower the levels of type-I IFN-stimulated genes in the plasma and cryopreserved PBMCs of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period.
Exploratory objectives
To assess the ability of lamivudine to modify retrotransposons expression in cryopreserved PBMCs the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Lamivudine 300 MG
- Keywords
- Alzheimer, biomarkers
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamivudine 300 MGDrug
Participants receive 300 mg of Lamivudine daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lamivudine 300 | Other | Participants receive 300 mg of Lamivudine daily for 24 weeks Receives: Drug: Lamivudine 300 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the ability of lamivudine to lower the levels of neurocognitive impairment biomarkers in the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period.
Percentage of change of pTau-217, total Tau, NfL, GFAP, Aβ42, Aβ40, and ratio in plasma from baseline visit to week 24 visit.
Measured: 24 weeks
To assess the incidence, nature, and severity of Treatment Emergent Adverse Events (TEAE).
Safety and tolerability as measured by incidence, nature, and severity of treatment adverse events (AE), serious AE (SAE), and AE leading to withdrawal.
Measured: 48 weeks
Secondary outcomes (1)
To assess the ability of lamivudine to lower the levels of type-I IFN-stimulated genes in the plasma and cryopreserved PBMCs of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period.
Fold change of type-I IFN-stimulated genes in plasma and cryopreserved PBMCs from baseline visit to week 24 visit.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start28 Oct 2024
- Primary completion5 Sep 2025
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Self-controlled, prospective case series pilot study
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Collaborators
- IrsiCaixa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519357
- Sponsor's protocol ID
- Lamiferon
- Status last verified
- Jun 2025
- First submitted
- 19 Jul 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Self-controlled, Prospective Case Series Pilot Study to Assess the Effect of Lamivudine (3TC) on Neurocognitive Impairment Biomarkers and Type-I IFN (Interferon)-Stimulated Genes in the Plasma of Patients With Mild Cognitive Impairment (MCI)
- ClinicalTrials.gov ID
- NCT06519357
- Acronym / sponsor ID
- Lamiferon
- Conditions
- Mild Cognitive Impairment
- Keywords
- Alzheimer, biomarkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Collaborators
- IrsiCaixa
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- Mar 2026 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the ability of lamivudine to lower the levels of neurocognitive impairment biomarkers in the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period.
To assess the incidence, nature, and severity of Treatment Emergent Adverse Events (TEAE).
Detailed description
To assess the ability of lamivudine to lower the levels of type-I IFN-stimulated genes in the plasma and cryopreserved PBMCs of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period.
Exploratory objectives
To assess the ability of lamivudine to modify retrotransposons expression in cryopreserved PBMCs the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Self-controlled, prospective case series pilot study
| Arm | Type | Receives |
|---|---|---|
| Lamivudine 300 | Other | Drug: Lamivudine 300 MGParticipants receive 300 mg of Lamivudine daily for 24 weeks |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female participants 55 to 90 years of age (both inclusive) at the time of signing the informed consent.
- Diagnosis of prodromal AD: MCI due to AD according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria as determined by a neurologist, geriatrician, psychiatrist, or clinician approved by the Sponsor or designee.
- Clinical Dementia Rating (CDR)-Global Score of 0.5
- Imaging studies (MRI or CT) within 21 years prior to screening that exclude secondary causes of dementia.
- that has findings consistent with AD and without any other disease that may cause dementia.
Key exclusion criteria (27 listed)
- Any other cause of dementia shown by MRI or CT findings within 2 years of screening and neurological examination at screening.
- Possible, probable, or definite vascular dementia according to the National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences (NINDS-AIREN) criteria.
- Evidence of significant abnormality that would suggest another potential etiology for dementia (e.g., evidence of cerebral contusion, encephalomalacia, aneurysm, vascular malformation, > 10 microhemorrhages, macrohemorrhage, single infarct > 1 cm3).
- Other central nervous system diseases that may cause cognitive impairment (e.g., cerebrovascular disease including cerebrovascular dementia, Parkinsonism, Huntington's disease, subdural hematoma, normal pressure hydrocephalus, brain tumor, Creutzfeldt-Jakob disease).
- Concurrent or history of clinically significant psychiatric conditions (e.g., schizophrenia or bipolar affective disorder) that in the Investigator's opinion prevents the participant from participating or is likely to confound interpretation of drug effect or affect cognitive assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lamivudine 300 MGParticipants receive 300 mg of Lamivudine daily for 24 weeks | Drug | Lamivudine 300 |
Primary outcome
To assess the ability of lamivudine to lower the levels of neurocognitive impairment biomarkers in the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period.
Time frame: 24 weeks
Percentage of change of pTau-217, total Tau, NfL, GFAP, Aβ42, Aβ40, and ratio in plasma from baseline visit to week 24 visit.
To assess the incidence, nature, and severity of Treatment Emergent Adverse Events (TEAE).
Time frame: 48 weeks
Safety and tolerability as measured by incidence, nature, and severity of treatment adverse events (AE), serious AE (SAE), and AE leading to withdrawal.
1 secondary outcome
To assess the ability of lamivudine to lower the levels of type-I IFN-stimulated genes in the plasma and cryopreserved PBMCs of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period.
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lamivudine 300 MG in people with Mild Cognitive Impairment, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the ability of lamivudine to lower the levels of neurocognitive impairment biomarkers in the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period. (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025; AzTrials last refreshed its copy on 2 Nov 2026.