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.

NCT06185543 | Terminated Phase 2

• 1 other identifier: NST-AD-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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)

  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)

  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)

  12 months

Other Outcomes (1)

• Exploratory

  12 months

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

PrimeC DRUG

Ciprofloxacin and celecoxib combination extended release formulation

PrimeC

Placebo DRUG

Placebo matches active drug in size, color and taste

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \< BMI \< 30
• 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)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• NeuroSense Therapeutics Ltd.: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 29, 2023
• Study Start: November 19, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

IL (1)