Alzheimer DiseasePhase 2NCT03282916
Anti-viral Therapy in Alzheimer's Disease
A Phase 2 study testing Valacyclovir in people with Alzheimer Disease and Herpes Simplex 1, run by Columbia University at 3 sites in United States.
Trial summary
Anti-viral therapy in Alzheimer's disease will investigate the efficacy of treating patients with mild Alzheimer's disease with the U.S.A marketed generic anti-viral drug Valtrex (valacyclovir, 500mg oral tablet). Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Alzheimer Disease, Herpes Simplex 1, Herpes Simplex 2
- What is being tested?
- Valacyclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Feb 2018to 5 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females. Females must be postmenopausal defined as 12 consecutive months without menstruation. Patient Report
- Diagnosis of probable AD by NIA clinical diagnostic criteria. Physician Evaluation
- Folstein Mini Mental State (MMSE) score 18 to 28 (inclusive) out of 30. Neuropsychological Evaluation
- Clinical Dementia Rating (CDR) score of 1 (mild dementia). Physician Evaluation
- A family member or other individual who is in contact with the patient and consents to serve as informant during the study Patient Report
- Patient retains capacity to consent for him/herself or retains the capacity to identify a surrogate who will consent on his/her behalf. Patient Report
Show all 10Show fewer
- At screening, patients must test positive for serum antibodies to HSV1 or HSV2. Patients that test equivocal (index between 0.90-1.09; < 0.90 is negative and > 1.09 is positive) will repeat the test within 6 weeks at a repeat visit. If the results are negative at the second test, the patient will not enter the study. If the results are equivocal or positive at the second test (first test was equivocal), we will enroll the patient in the study because "equivocal" indicates the presence of antibodies that do not reach the minimum threshold.
- Use of cholinesterase inhibitors and memantine, and concomitant psychotropic medications (other than high dose benzodiazepines), will be permitted throughout the trial. Doses of these medications will need to be stable for at least 1 month prior to study entry. Any changes to the medication will be documented in the participant research chart. Medications given for other medical reasons, e.g., anti-diabetic or antihypertensive medications, will not be altered for the purposes of this trial and the patient's primary physician may adjust such medications as medically indicated throughout the trial. Details of concomitant medication use will be documented at all visits and will be available for statistical analysis.
- For patients diagnosed with Mild Cognitive Impairment and CDR score of 0.5 ( questionable dementia), if these patients have biomarkers of AD neuropathology with either a positive amyloid PET scan, positive fluorodeoxyglucose (FDG) PET scan of the brain, or positive findings for AD in CSF ( low ABeta42 and high tau, p-tau protein levels) they will be eligible for the study. This applies to patients who already had an amyloid PET scan, FDG PET scan of the brain, or lumbar puncture, prior to recruitment into the protocol.
- Physical Evaluation
Who cannot join
- Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions. Physician Evaluation
- Patient has dementia predominantly of non-Alzheimer's type, including vascular dementia, frontotemporal dementia, Lewy body dementia, substance-induced dementia. Physician Evaluation
- Modified Hachinski scale score greater than 4. Physician Evaluation
- Current clinical diagnosis of schizophrenia, schizoaffective disorder, other psychosis, bipolar disorder or current major depression by DSM-5 criteria. Prior history of major depression will not be exclusionary (25% of older adults have a lifetime history of major depression). Physician Evaluation
- Active suicidal intent or plan based on clinical assessment. Physician Evaluation
- Current or recent (past 6 months) alcohol or substance use disorder (DSM-5 criteria). Physician Evaluation
Show all 19Show fewer
- Current diagnosis of other major neurological disorders, including Parkinson's disease, multiple sclerosis, CNS infection, Huntington's disease, and amyotrophic lateral sclerosis. Physician Evaluation
- Clinical stroke with residual neurological deficits. MRI findings of cerebrovascular disease (small infarcts, lacunes, periventricular disease) in the absence of clinical stroke with residual neurological deficits will not lead to exclusion. Physician Evaluation
- Acute, severe, unstable medical illness. For cancer, patients with active illness or metastases in the last 12 months will be excluded, but past history of successfully treated cancer will not lead to exclusion. Physician Evaluation
- Sitting blood pressure > 160/100 mm Hg. Physician Evaluation
- Renal failure as determined by an estimated Glomerular Filtration Rate (GFR) < 44 ml/min/1.73m2 (see 4.3.b.). Physician Evaluation/ Laboratory Report
- Serum vitamin B12 levels below the normal range. Physician Evaluation/ Laboratory Report
- Patients with thrombotic thrombocytopenic purpura/hemolytic uremic syndrome will be excluded. Physician Evaluation
- Use of benzodiazepines in lorazepam equivalent doses equal to or greater than 2 mg daily. Physician Evaluation
- For patients consenting to lumbar puncture (40% of sample), this procedure will be conducted if there is no lower spinal malformation or other contraindication to lumbar puncture. Physician Evaluation
- For MRI, metal implants and pacemaker, and claustrophobia such that the patient refuses MRI. In the investigators' experience, these exclusions occur in less than 5% of patients with mild AD. MRI is required for VALAD. Patient Report/ Physician Evaluation
- Radiation exposure in the prior 12 months that, together with 18F-Florbetapir and 18F--MK-6240 PET, will be above the FDA annual radiation exposure threshold. This will be determined through study staff ( i.e. Principal Investigator, Study Physician) discussion with potential subjects at Screening, documenting inquiry about radiation history. If there is any history of additional radiation exposure in the past year; it will be reviewed with PET Center staff for their approval before proceeding. The combined radiation exposure from the maximum doses used for 18F-Florbetapir and 18F-MK- 6240 is within the FDA limits for annual radiation exposure and the second scan in each patient will be done 18 months after the initial PET scan (for both radioligands). Patient Report/Physician Evaluation
- Severe vision or hearing impairment that would prevent the participant from performing the psychometric tests accurately. This will be a clinical determination by the study physician without formal testing or audiometry Physician Evaluation
- Olfaction component: current upper respiratory infection (patient tested as soon as this improves), current smoker > 1 pack daily (past smoking has been shown not to affect UPSIT scores, UPSIT score < 12/40 (10 out of 40 is scored by chance in this multiple-choice test) indicating congenital anosmia. In the investigators' experience, less than 3% of cases are excluded for having one or more of these exclusionary criteria. If a patient is excluded from the olfaction component, the patient will still be eligible for the main protocol and all other study procedures. Patient Report/Physician Evaluation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New York University School of Medicine
New York, New York, 10016
New York State Psychiatric Institute
New York, New York, 10032
Banner Alzheimer's Institute (BAI)
Phoenix, Arizona, 85006
About this study
Anti-viral therapy in Alzheimer's disease will investigate the efficacy of treating patients with mild Alzheimer's disease with the U.S.A marketed generic anti-viral drug Valtrex (valacyclovir, 500mg oral tablet). Valacyclovir, titrated to 4 grams per day, repurposed to treat Alzheimer's disease, will be compared to matching placebo in the treatment of 130 mild AD patients (65 valacyclovir, 65 placebo) who test positive for herpes simplex virus-1 (HSV1) or herpes simplex virus-2 (HSV2). The study will be a randomized, double-blind, 18-month Phase II proof of concept trial.
Read the detailed description
Many viruses are latent for decades before being reactivated in the brain by stress, immune compromise, or other factors. After the initial oral infection, herpes simplex virus-1 (HSV1) becomes latent in the trigeminal ganglion and can later enter the brain via retrograde axonal transport, often targeting the temporal lobes.
HSV1 can also enter the brain via olfactory neurons directly. HSV1 (oral herpes) and HSV2 (genital herpes) are known to trigger amyloid aggregation and their DNA is commonly found in amyloid plaques. Anti-HSV drugs reduce Aβ and p-tau accumulation in brains of infected mice. HSV1 reactivation is associated with tau hyperphosphorylation in mice and may play a role in tau propagation across neurons. In humans, recurrent reactivation with newly produced HSV1 particles, 'drop by drop,' may produce neuronal damage and eventually lead to neurodegeneration and Alzheimer's disease (AD) pathology, partly due to effects on amyloid and tau. Clinical studies show cognitive impairment in HSV seropositive patients in different patient groups and in healthy adults, and antiviral treatments show robust efficacy against peripheral HSV infection. The study team will conduct the first-ever clinical trial to directly address the long-standing viral etiology hypothesis of AD which posits that viruses, particularly the very common HSV1 and HSV2, may be etiologic or contribute to the pathology of AD. In patients with mild AD who test positive for serum antibodies to HSV1 or HSV2, the generic antiviral drug valacyclovir, repurposed as an anti-AD drug, will be compared at oral doses of 4 grams per day, to matching placebo in the treatment of 130 patients (65 valacyclovir, 65 placebo) in a randomized, double-blind, 78-week Phase II proof of concept trial. Patients treated with valacyclovir are hypothesized to show smaller decline in cognition and functioning compared to placebo, and, using 18F-Florbetapir PET imaging, to show less amyloid accumulation than placebo over the 78-week trial. Through the use of tau PET imaging with the tracer 18F-MK-6240 at baseline and 78 weeks, patients treated with valacyclovir are hypothesized to show smaller increases in 18F-MK-6240 binding than patients treated with placebo from baseline to 78 weeks. Apolipoprotein E genotype at baseline, as well as changes in cortical thinning on structural MRI, olfactory identification deficits, and antiviral antibody titers from baseline to 78 weeks, will be evaluated in exploratory analyses. In patients who agree to lumbar puncture, plasma and CSF acyclovir will be assayed to establish the degree of CNS penetration of valacyclovir in mild AD, and the investigators will obtain CSF Aβ42, tau, p-tau for subset exploratory analyses with changes in outcome measures. If this trial is successful, the investigators will apply for funding to conduct a larger, multicenter, Phase III study using a study design that will be informed by the results of this Phase II trial. This innovative Phase II proof of concept trial clearly has exceptionally high reward potential for the treatment of AD.
- Conditions
- Alzheimer Disease, Herpes Simplex 1, Herpes Simplex 2
- Being tested
- Valacyclovir, Placebo
- Keywords
- Valacyclovir, Anti-viral treatment
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValacyclovirDrug
Also called Valtrex
Valacyclovir hydrochloride 500mg caplet
PlaceboDrug
Placebo sugar pill 500mg caplet
| Study group | Role | What they receive |
|---|---|---|
| Valacyclovir | Active comparator | The oral valacyclovir will be distributed in 500mg caplets. Patients will take 8 caplets per day. Receives: Drug: Valacyclovir |
| Placebo | Placebo comparator | The oral placebo (sugar pill) will be distributed in 500mg caplets. Patients will take 8 caplets per day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale - Cognition (ADAS-COG11, Modified Version) Score
The modified ADAS-COG11 is a neuropsychological test used to measure the severity of cognitive dysfunction in Alzheimer's disease. The full range is 0 to 70, where a higher score indicates worse cognition.
Measured: Baseline, Week 78
Secondary outcomes (3)
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score
ADCS-ADL is a caregiver-reported scale to assess a patient's ability to perform everyday tasks. The full score range 0 to 78, with higher scores indicating better functioning.
Measured: Baseline, Week 78
Total 18F-Florbetapir Brain Uptake
18F-Florbetapir PET imaging will show amyloid accumulation in a sum of six ROIs (Region of Interest) (cerebellar reference) that show increased uptake in AD: medial orbital frontal, anterior cingulate, parietal, temporal, posterior cingulate, precuneus. The full range is approximately 0 to 4 SUVR (Standardized Uptake Value Ratio), with higher SUVR indicating more amyloid.
Measured: Baseline, Week 78
Total 18F-MK-6240 Temporal Lobe Brain Uptake
18F-MK-6240 tau PET imaging will show tau accumulation, SUVR: average of medial temporal regions (amygdala, hippocampus, entorhinal, parahippocampus) with cerebellar reference. The full range is approximately 0 to 5 SUVR, with higher SUVR indicating more tau accumulation.
Measured: Baseline, Week 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start12 Feb 2018
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Devangere P. Devanand, Columbia University
- Investigators
- Davangere Devanand, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282916
- Sponsor's protocol ID
- AAAV1800
- Other IDs
- R01AG055422, NYSPI 7537
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2017
- Last updated
- 25 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Devanand DP, Wisniewski T, Razlighi Q, Qian M, Wei R, Andrews HF, Acosta EP, Bell KL, Pelton GH, Deliyannides D, Perrin AC, Caccappolo E, Gershon AA, Prasad KM, Kreisl WC, Mintz A, Huey ED. Valacyclovir Treatment of Early Symptomatic Alzheimer Disease: The VALAD Randomized Clinical Trial. JAMA. 2026 Feb 10;335(6):511-522. doi: 10.1001/jama.2025.21738.
PubMed 41405855Devanand DP, Andrews H, Kreisl WC, Razlighi Q, Gershon A, Stern Y, Mintz A, Wisniewski T, Acosta E, Pollina J, Katsikoumbas M, Bell KL, Pelton GH, Deliyannides D, Prasad KM, Huey ED. Antiviral therapy: Valacyclovir Treatment of Alzheimer's Disease (VALAD) Trial: protocol for a randomised, double-blind,placebo-controlled, treatment trial. BMJ Open. 2020 Feb 6;10(2):e032112. doi: 10.1136/bmjopen-2019-032112.
PubMed 32034019
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-viral Therapy in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03282916
- Acronym / sponsor ID
- AAAV1800
- Conditions
- Alzheimer Disease, Herpes Simplex 1, Herpes Simplex 2
- Keywords
- Valacyclovir, Anti-viral treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Posted 8 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anti-viral therapy in Alzheimer's disease will investigate the efficacy of treating patients with mild Alzheimer's disease with the U.S.A marketed generic anti-viral drug Valtrex (valacyclovir, 500mg oral tablet). Valacyclovir, titrated to 4 grams per day, repurposed to treat Alzheimer's disease, will be compared to matching placebo in the treatment of 130 mild AD patients (65 valacyclovir, 65 placebo) who test positive for herpes simplex virus-1 (HSV1) or herpes simplex virus-2 (HSV2). The study will be a randomized, double-blind, 18-month Phase II proof of concept trial.
Detailed description
Many viruses are latent for decades before being reactivated in the brain by stress, immune compromise, or other factors. After the initial oral infection, herpes simplex virus-1 (HSV1) becomes latent in the trigeminal ganglion and can later enter the brain via retrograde axonal transport, often targeting the temporal lobes.
HSV1 can also enter the brain via olfactory neurons directly. HSV1 (oral herpes) and HSV2 (genital herpes) are known to trigger amyloid aggregation and their DNA is commonly found in amyloid plaques. Anti-HSV drugs reduce Aβ and p-tau accumulation in brains of infected mice. HSV1 reactivation is associated with tau hyperphosphorylation in mice and may play a role in tau propagation across neurons. In humans, recurrent reactivation with newly produced HSV1 particles, 'drop by drop,' may produce neuronal damage and eventually lead to neurodegeneration and Alzheimer's disease (AD) pathology, partly due to effects on amyloid and tau. Clinical studies show cognitive impairment in HSV seropositive patients in different patient groups and in healthy adults, and antiviral treatments show robust efficacy against peripheral HSV infection. The study team will conduct the first-ever clinical trial to directly address the long-standing viral etiology hypothesis of AD which posits that viruses, particularly the very common HSV1 and HSV2, may be etiologic or contribute to the pathology of AD. In patients with mild AD who test positive for serum antibodies to HSV1 or HSV2, the generic antiviral drug valacyclovir, repurposed as an anti-AD drug, will be compared at oral doses of 4 grams per day, to matching placebo in the treatment of 130 patients (65 valacyclovir, 65 placebo) in a randomized, double-blind, 78-week Phase II proof of concept trial. Patients treated with valacyclovir are hypothesized to show smaller decline in cognition and functioning compared to placebo, and, using 18F-Florbetapir PET imaging, to show less amyloid accumulation than placebo over the 78-week trial. Through the use of tau PET imaging with the tracer 18F-MK-6240 at baseline and 78 weeks, patients treated with valacyclovir are hypothesized to show smaller increases in 18F-MK-6240 binding than patients treated with placebo from baseline to 78 weeks. Apolipoprotein E genotype at baseline, as well as changes in cortical thinning on structural MRI, olfactory identification deficits, and antiviral antibody titers from baseline to 78 weeks, will be evaluated in exploratory analyses. In patients who agree to lumbar puncture, plasma and CSF acyclovir will be assayed to establish the degree of CNS penetration of valacyclovir in mild AD, and the investigators will obtain CSF Aβ42, tau, p-tau for subset exploratory analyses with changes in outcome measures. If this trial is successful, the investigators will apply for funding to conduct a larger, multicenter, Phase III study using a study design that will be informed by the results of this Phase II trial. This innovative Phase II proof of concept trial clearly has exceptionally high reward potential for the treatment of AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valacyclovir | Active comparator | Drug: ValacyclovirThe oral valacyclovir will be distributed in 500mg caplets. Patients will take 8 caplets per day. |
| Placebo | Placebo comparator | Drug: PlaceboThe oral placebo (sugar pill) will be distributed in 500mg caplets. Patients will take 8 caplets per day. |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females. Females must be postmenopausal defined as 12 consecutive months without menstruation. Patient Report
- Diagnosis of probable AD by NIA clinical diagnostic criteria. Physician Evaluation
- Folstein Mini Mental State (MMSE) score 18 to 28 (inclusive) out of 30. Neuropsychological Evaluation
- Clinical Dementia Rating (CDR) score of 1 (mild dementia). Physician Evaluation
- A family member or other individual who is in contact with the patient and consents to serve as informant during the study Patient Report
Key exclusion criteria (19 listed)
- Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions. Physician Evaluation
- Patient has dementia predominantly of non-Alzheimer's type, including vascular dementia, frontotemporal dementia, Lewy body dementia, substance-induced dementia. Physician Evaluation
- Modified Hachinski scale score greater than 4. Physician Evaluation
- Current clinical diagnosis of schizophrenia, schizoaffective disorder, other psychosis, bipolar disorder or current major depression by DSM-5 criteria. Prior history of major depression will not be exclusionary (25% of older adults have a lifetime history of major depression). Physician Evaluation
- Active suicidal intent or plan based on clinical assessment. Physician Evaluation
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 |
|---|---|---|
| ValacyclovirAlso: ValtrexValacyclovir hydrochloride 500mg caplet | Drug | Valacyclovir |
| PlaceboPlacebo sugar pill 500mg caplet | Drug | Placebo |
Primary outcome
Alzheimer's Disease Assessment Scale - Cognition (ADAS-COG11, Modified Version) Score
Time frame: Baseline, Week 78
The modified ADAS-COG11 is a neuropsychological test used to measure the severity of cognitive dysfunction in Alzheimer's disease. The full range is 0 to 70, where a higher score indicates worse cognition.
3 secondary outcomes
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score
Time frame: Baseline, Week 78
Total 18F-Florbetapir Brain Uptake
Time frame: Baseline, Week 78
Total 18F-MK-6240 Temporal Lobe Brain Uptake
Time frame: Baseline, Week 78
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41405855Devanand DP, Wisniewski T, Razlighi Q, Qian M, Wei R, Andrews HF, Acosta EP, Bell KL, Pelton GH, Deliyannides D, Perrin AC, Caccappolo E, Gershon AA, Prasad KM, Kreisl WC, Mintz A, Huey ED. Valacyclovir Treatment of Early Symptomatic Alzheimer Disease: The VALAD Randomized Clinical Trial. JAMA. 2026 Feb 10;335(6):511-522. doi: 10.1001/jama.2025.21738.
- Derived from this study: PubMed 32034019Devanand DP, Andrews H, Kreisl WC, Razlighi Q, Gershon A, Stern Y, Mintz A, Wisniewski T, Acosta E, Pollina J, Katsikoumbas M, Bell KL, Pelton GH, Deliyannides D, Prasad KM, Huey ED. Antiviral therapy: Valacyclovir Treatment of Alzheimer's Disease (VALAD) Trial: protocol for a randomised, double-blind,placebo-controlled, treatment trial. BMJ Open. 2020 Feb 6;10(2):e032112. doi: 10.1136/bmjopen-2019-032112.
- 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.
Davangere Devanand, MD principal investigator
Columbia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valacyclovir in people with Alzheimer Disease and Herpes Simplex 1, run by Columbia University at 3 sites in United States.
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 10 inclusion and 19 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: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 8 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Alzheimer's Disease Assessment Scale - Cognition (ADAS-COG11, Modified Version) Score (time frame: Baseline, Week 78). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03282916, which also lists 2 linked publications.
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 25 Sep 2025.