Evaluation of the Safety and Efficacy of NeuroEPO in Subjects With Mild to Moderate Alzheimer's Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Saskatchewan
About this trial
The goal of this clinical trial is to test if NeuroEPO improves or maintains cognition in adults with mild to moderate Alzheimer's Disease using a cannula attached to a syringe for delivery. It will also learn the safety of NeuroEPO. The main questions it aims to answer are:
Does NeuroEPO lower or maintain a person's cognition who has been diagnosed with Alzheimer's Disease? What medical problems do participants have when taking NeuroEPO?
Researchers will compare NeuroEPO to a placebo (a look-alike substance that contains no drug) to see if NeuroEPO works to treat Alzheimer's Disease.
Participants will:
Take NeuroEPO or a placebo three times a week for one year Visit the clinic to determine eligibility, for cognitive testing and blood tests at the start and end of the trial and at 1, 2, 6 and 12 months for check ups and blood collection
Eligibility criteria
Qualifiers
Patients >= 50 years of age, to reflect the population that will be treated and to avoid younger populations who may be suffering dementia from a cause other than Alzheimer's Disease.
Patients with Global Deterioration Scale (GDS) between 3 to 5 points (inclusive).
Clinical Dementia Rating (CDR) - GS score 1-2 at screening.
Patients with permeable airways.
Disqualifiers
Evident mental disability or other limitation that prevents the patient or caregiver from administering the study evaluations.
Patients with neurological symptoms or signs that suggest another cause of dementia.
Skull trauma or recent intracranial surgery.
Known clotting disorders.
Trial design
Treatments tested in this trial
- NeuroEPO
- Placebo
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Saskatchewan
Lead sponsor
Center of Molecular Immunology, Cuba
Collaborator
Source ClinicalTrials.gov