Alzheimer DiseasePhase 2RoADNCT06185543
A Phase 2, Randomized, Prospective Double-Blind, Single-Center, Placebo-controlled Study to Evaluate Safety, Tolerability, Target Engagement, and Efficacy of PrimeC in Patients With Mild to Moderate Alzheimer's Disease.
A Phase 2 study testing PrimeC in people with Alzheimer Disease, run by NeuroSense Therapeutics Ltd. at 1 site in Israel.
Trial summary
20 subjects with mild to moderate AD will be enrolled in the study and randomized at a 1:1 ratio to receive the study drug or placebo tablets, respectively. All subjects will be administered the drug/placebo twice daily (BID), two tablets each time, for 52 weeks. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- PrimeC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Nov 2023to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to comprehend and willing to sign an informed consent form (ICF) and their ability to consent was estimated by an independent Neurologist or Geriatrist.
- Males or females between the ages of 55 and 85 years of age, inclusive
- Diagnosis of probable AD with evidence of the AD pathophysiological process according to the diagnostic criteria of the National Institute on Aging and Alzheimer's Association
- AD patients with a score of 18 to 24 on MMSE at screening.
- Subjects may be treated in parallel with rivastigmine, donepezil, galantamine, memantine, donezepil, aducanumab, and lecanemab or their combination. For rivastigmine, donepezil, galantamine, memantine, donezepil - 30 days of stable use prior to enrollment is required. For aducanumab and lecanemab - 3 months of stable use prior to enrollment is required.
- 18 < BMI < 30
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- Patients who have a caregiver - the caregiver shall be in contact with the patient at least 10 hours per week, and can attend all visits with the patient, report on the subject's status and verify compliance with all study requirements.
- CT or MRI available within 12 months before the enrolment to the study devoid of any structural finding which could explain the cognitive impairment, except for brain atrophy or white matter hyperintensities which can be observed in AD patients.
- CT or MRI available within 3 months before the lumbar puncture.
- Presence of pTau 181 in CSF at screening
- Female with no childbearing potential (at least 1 year postmenopausal or surgical contraception)
Who cannot join
- Any significant neurologic or medical disorders other than AD, which might be the cause of the existing cognitive deficit, such as: other neurodegenerative disease, Hydrocephalus including NPH, seizures, Huntington's disease, Amyotrophic lateral sclerosis, multiple sclerosis, systemic lupus erythematosus, progressive supranuclear palsy, neurosyphilis, HIV, learning disability, intellectual disability, hypoxic cerebral damage, relevant neoplasm, toxic exposure, or any significant medical conditions that, in the opinion of the PI would endanger the health and wellbeing of the participant.
- Stroke or Transient Ischemic Attack (TIA) within 6 months of screening visit.
- History of severe head trauma with documented loss of consciousness or with radiological findings associated with the injury, leading to other neurological deficits.
- Any contraindication to conduct lumber puncture.
- Major depressive disorder according to DSM-V criteria requiring hospitalization within the previous 90 days before screening.
- Suicidal ideation and behavior assessed by C-SSRS.
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- Serum B12 clinically significantly below the lower limit of normal at screening
- Patients with history or current evidence of clinical significant peripheral neuropathy. The severity of the peripheral neuropathy will be determined by the investigator.
- Patients who take tizanidine
- Patients with history or current clinically significant of psychiatric disorders (e.g., anxiety, depression, delirium) occurring within the last two years, which required the subject to be hospitalized.
- Patients with known history of myasthenia gravis or myasthenic syndrome
- No psychotropics can be started during the trial except for short acting hypnotics for sleep and or low potency neuroleptics for agitation.
- If the patient is taking antipsychotic, antidepressant, antianxiety or any other psychotropic before enrollment to the study there was no dose change 30 days before enrollment.
- A past history of adverse reaction/hypersensitivity to either NSAIDs, celecoxib or fluoroquinolones, ciprofloxacin and / or to the non-active components of PrimeC: Microcrystalline cellulose Avicel, Povidone K-30, Sodium lauryl sulphate, Hydroxy propyl methyl cellulose, Microcrystalline cellulose, Colloidal Silicon Dioxide, Magnesium Stearate, and Opadry Blue.
- Any known clinically significant abnormal gastric mucosal erosion, ulcer or tumor or/and GI disorder and/or bariatric surgery
- Known history of clinically significant impairment of renal function (eGFR < 60)
- Known or suspected symptomatic congestive heart and/or coronary heart disease, previous history of myocardial infarction, CABG, uncontrolled arterial hypertension, or rhythm abnormalities requiring permanent treatment
- Known history of QT/QTc prolongation, Torsade de pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT syndrome) and the use of concomitant medications that prolong the QT/QTc interval.
- Patients with known aortic aneurysms and heart valve regurgitation/incompetence.
- Known or suspected diagnosis or family history of epilepsy in first degree relatives.
- Known predisposition to tendinitis.
- Known Impaired hepatic function.
- Known or suspected to be a poor CYP2C9 metabolizer who also uses pharmacologic agents (prescription or over-the-counter) or herbal products known or suspected to induce or inhibit CYP2C9 within 30 days before enrollment.
- Presence at screening of any medically significant cardiac, pulmonary, musculoskeletal, or psychiatric illness that might interfere with the subject's ability to comply with study procedures or that might confound the interpretation of clinical safety data, including, but not limited to:
- Mean systolic blood pressure >160 mm Hg and/or mean diastolic blood pressure >100 mm Hg (measurements taken after a few minutes rest) that persist on 3 successive measurements taken at least 2 minutes apart
- NYHA Class II or greater congestive heart failure
- Chronic obstructive pulmonary disease or asthma requiring daily use of bronchodilator medications
- Uncontrolled diabetes mellitus
- Subject who is treated with chronic aspirin or NSAIDs and is at risk if stopped. Clopidogrel is allowed and can replace Aspirin.
- Any contraindication for ciprofloxacin and celecoxib according to the current prescribing information.
- Any impairment or social circumstance that, in the opinion of the Investigator, would render the subject not suitable to participate in the study.
- Subject, or subject's legal guardian(s) is/are unable to understand the nature, scope, and possible consequences of the study.
- Subject is participating in (or plans to participate in) any other investigational drug trial or plans to be exposed to any other investigational agent, device and/or procedure, from 30 days prior to Screening through study completion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Randomized, Prospective Double-Blind, Single-Center, Placebo-controlled Study to Evaluate Safety, Tolerability, Target Engagement, and Efficacy of PrimeC in Patients With Mild to Moderate Alzheimer's Disease (AD)
20 subjects with mild to moderate AD will be enrolled in the study and randomized at a 1:1 ratio to receive the study drug or placebo tablets, respectively. All subjects will be administered the drug/placebo twice daily (BID), two tablets each time, for 52 weeks.
Subjects will be allowed to receive standard of care (SOC) treatment of approved products or their combination. Subjects will be evaluated every 3 months for safety and tolerability.
Read the detailed description
This is a Phase II, Randomized, Single-center, Prospective, Double-Blind, Placebo-Controlled Study, to evaluate Safety, Tolerability, target engagement and efficacy of PrimeC in subjects with mild to moderate AD. Subjects who meet the inclusion criteria and none of the exclusion criteria and who provide a signed Informed Consent will be enrolled in the study.
20 subjects with mild to moderate AD will be enrolled in the study and randomized at a 1:1 ratio to receive the study drug or placebo tablets, respectively. All subjects will be administered the drug/placebo twice daily (BID), two tablets each time, for 52 weeks.
Subjects will be allowed to receive standard of care (SOC) treatment of approved products or their combination (rivastigmine, donepezil, galantamine, memantine, donezepil, aducanumab, and lecanemab).
Subjects will be evaluated every 3 months for safety and tolerability (adverse events, safety laboratory, vital signs, ECG, withdrawal rates and reasons). Subjects will be evaluated for efficacy at baseline and after 12 months for CSF biomarkers and clinical outcomes (CDR, ADAS COG 14, ADCS-iADL, MMSE), for blood biomarkers at baseline, 6 and 12 months, and for C-SSRS every 3 months. A remote follow up (via phone call) will be conducted 1 month after baseline visit in order to confirm investigational drug compliance according to the protocol and potential AEs.
Adverse events (AEs) including any death, will be recorded throughout the study.
During the study, the sponsor, the PI, the outcome assessor, the subjects and all staff involved in the collection and recording of the clinical and laboratory data will be blinded to the treatment assignment. In addition, all aspects of data management and clean-up will be done using blinded datasets.
Following completion of 12 months of treatment, data lock will be performed, and data will be analyzed.
- Conditions
- Alzheimer Disease
- Being tested
- PrimeC, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrimeCDrug
Ciprofloxacin and celecoxib combination extended release formulation
PlaceboDrug
Placebo matches active drug in size, color and taste
| Study group | Role | What they receive |
|---|---|---|
| PrimeC | Active comparator | 2 tablets of PrimeC administered twice daily (4 tablets a day), total daily dose of 1360 mg ciprofloxacin and 136 mg celecoxib orally. Receives: Drug: PrimeC |
| Placebo | Placebo comparator | 2 tablets of Placebo administered twice daily (4 tablets a day). Placebo tablets are matched in size, color and taste. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety and tolerability of PrimeC in mild to moderate AD patients (change from baseline to 12 months)
- Incidence and severity of treatment-emergent adverse events (TEAEs)
- Number (%) of subjects who discontinued treatment prematurely
- Number (%) of subjects who discontinued treatment prematurely due to AEs
- Number (%) of subjects with clinically significant abnormal laboratory values following treatment
Measured: 12 months
Secondary outcomes (4)
To assess the effect of PrimeC on cognitive functioning and activities of daily living in mild to moderate AD patients (change from baseline to 12 months)
The mean difference from baseline to 12 months between PrimeC and Placebo in Clinical Dementia Rating Scale (CDR)
Measured: 12 months
To assess the effect of PrimeC on cognitive functioning and activities of daily living in mild to moderate AD patients (change from baseline to 12 months)
- The mean difference from baseline to 12 months between PrimeC and Placebo in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog 14)
Measured: 12 months
To assess the effect of PrimeC on cognitive functioning and activities of daily living in mild to moderate AD patients (change from baseline to 12 months)
- The mean difference from baseline to 12 months between PrimeC and Placebo in the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)
Measured: 12 months
To assess the effect of PrimeC on cognitive functioning and activities of daily living in mild to moderate AD patients (change from baseline to 12 months)
- The mean difference from baseline to 12 months between PrimeC and Placebo in the Mini-Mental State Examination (MMSE)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start19 Nov 2023
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Why it stopped: Company will improve study desig
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroSense Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185543
- Sponsor's protocol ID
- NST-AD-001
- Acronym
- RoAD
- Status last verified
- Apr 2026
- First submitted
- 28 Nov 2023
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Prospective Double-Blind, Single-Center, Placebo-controlled Study to Evaluate Safety, Tolerability, Target Engagement, and Efficacy of PrimeC in Patients With Mild to Moderate Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT06185543
- Acronym / sponsor ID
- RoAD / NST-AD-001
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company will improve study desig
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NeuroSense Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 29 Dec 2023 (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.
20 subjects with mild to moderate AD will be enrolled in the study and randomized at a 1:1 ratio to receive the study drug or placebo tablets, respectively. All subjects will be administered the drug/placebo twice daily (BID), two tablets each time, for 52 weeks.
Subjects will be allowed to receive standard of care (SOC) treatment of approved products or their combination. Subjects will be evaluated every 3 months for safety and tolerability.
Detailed description
This is a Phase II, Randomized, Single-center, Prospective, Double-Blind, Placebo-Controlled Study, to evaluate Safety, Tolerability, target engagement and efficacy of PrimeC in subjects with mild to moderate AD. Subjects who meet the inclusion criteria and none of the exclusion criteria and who provide a signed Informed Consent will be enrolled in the study.
20 subjects with mild to moderate AD will be enrolled in the study and randomized at a 1:1 ratio to receive the study drug or placebo tablets, respectively. All subjects will be administered the drug/placebo twice daily (BID), two tablets each time, for 52 weeks.
Subjects will be allowed to receive standard of care (SOC) treatment of approved products or their combination (rivastigmine, donepezil, galantamine, memantine, donezepil, aducanumab, and lecanemab).
Subjects will be evaluated every 3 months for safety and tolerability (adverse events, safety laboratory, vital signs, ECG, withdrawal rates and reasons). Subjects will be evaluated for efficacy at baseline and after 12 months for CSF biomarkers and clinical outcomes (CDR, ADAS COG 14, ADCS-iADL, MMSE), for blood biomarkers at baseline, 6 and 12 months, and for C-SSRS every 3 months. A remote follow up (via phone call) will be conducted 1 month after baseline visit in order to confirm investigational drug compliance according to the protocol and potential AEs.
Adverse events (AEs) including any death, will be recorded throughout the study.
During the study, the sponsor, the PI, the outcome assessor, the subjects and all staff involved in the collection and recording of the clinical and laboratory data will be blinded to the treatment assignment. In addition, all aspects of data management and clean-up will be done using blinded datasets.
Following completion of 12 months of treatment, data lock will be performed, and data will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrimeC | Active comparator | Drug: PrimeC2 tablets of PrimeC administered twice daily (4 tablets a day), total daily dose of 1360 mg ciprofloxacin and 136 mg celecoxib orally. |
| Placebo | Placebo comparator | Drug: Placebo2 tablets of Placebo administered twice daily (4 tablets a day). Placebo tablets are matched in size, color and taste. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able to comprehend and willing to sign an informed consent form (ICF) and their ability to consent was estimated by an independent Neurologist or Geriatrist.
- Males or females between the ages of 55 and 85 years of age, inclusive
- Diagnosis of probable AD with evidence of the AD pathophysiological process according to the diagnostic criteria of the National Institute on Aging and Alzheimer's Association
- AD patients with a score of 18 to 24 on MMSE at screening.
- Subjects may be treated in parallel with rivastigmine, donepezil, galantamine, memantine, donezepil, aducanumab, and lecanemab or their combination. For rivastigmine, donepezil, galantamine, memantine, donezepil - 30 days of stable use prior to enrollment is required. For aducanumab and lecanemab - 3 months of stable use prior to enrollment is required.
Key exclusion criteria (33 listed)
- Any significant neurologic or medical disorders other than AD, which might be the cause of the existing cognitive deficit, such as: other neurodegenerative disease, Hydrocephalus including NPH, seizures, Huntington's disease, Amyotrophic lateral sclerosis, multiple sclerosis, systemic lupus erythematosus, progressive supranuclear palsy, neurosyphilis, HIV, learning disability, intellectual disability, hypoxic cerebral damage, relevant neoplasm, toxic exposure, or any significant medical conditions that, in the opinion of the PI would endanger the health and wellbeing of the participant.
- Stroke or Transient Ischemic Attack (TIA) within 6 months of screening visit.
- History of severe head trauma with documented loss of consciousness or with radiological findings associated with the injury, leading to other neurological deficits.
- Any contraindication to conduct lumber puncture.
- Major depressive disorder according to DSM-V criteria requiring hospitalization within the previous 90 days before screening.
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 |
|---|---|---|
| PrimeCCiprofloxacin and celecoxib combination extended release formulation | Drug | PrimeC |
| PlaceboPlacebo matches active drug in size, color and taste | Drug | Placebo |
Primary outcome
To assess safety and tolerability of PrimeC in mild to moderate AD patients (change from baseline to 12 months)
Time frame: 12 months
* Incidence and severity of treatment-emergent adverse events (TEAEs) * Number (%) of subjects who discontinued treatment prematurely * Number (%) of subjects who discontinued treatment prematurely due to AEs * Number (%) of subjects with clinically significant abnormal laboratory values following treatment
4 secondary outcomes
To assess the effect of PrimeC on cognitive functioning and activities of daily living in mild to moderate AD patients (change from baseline to 12 months)
Time frame: 12 months
To assess the effect of PrimeC on cognitive functioning and activities of daily living in mild to moderate AD patients (change from baseline to 12 months)
Time frame: 12 months
To assess the effect of PrimeC on cognitive functioning and activities of daily living in mild to moderate AD patients (change from baseline to 12 months)
Time frame: 12 months
To assess the effect of PrimeC on cognitive functioning and activities of daily living in mild to moderate AD patients (change from baseline to 12 months)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Company will improve study desig). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 PrimeC in people with Alzheimer Disease, run by NeuroSense Therapeutics Ltd. at 1 site in Israel.
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 11 inclusion and 33 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: stopped early, as of the sponsor's last update on 9 Apr 2026. 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 Israel. 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?
The study was stopped early (reason given: Company will improve study desig). Results are not available in the source record.
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 safety and tolerability of PrimeC in mild to moderate AD patients (change from baseline to 12 months) (time frame: 12 months). 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 9 Apr 2026.