A Phase 2, Randomized, Prospective Double-Blind, Single-Center, Placebo-controlled Study to Evalu… (NCT06185543) | Clinical Trial Compass
TerminatedPhase 2
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.
Stopped: Company will improve study desig
Israel8 participantsStarted 2023-11-19
Plain-language 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.
Who can participate
Age range
55 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess safety and tolerability of PrimeC in mild to moderate AD patients (change from baseline to 12 months)
. 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.
Exclusion criteria
. 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.