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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
NeuroEPO
Drug0.5 mg of NeuroEPO will be administered intranasally three times a week for 52 weeks.
Placebo
Drug250 µL of placebo will be administered to intranasally to each nostril three times a week for 52 weeks.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: NeuroEPO + standard of careExperimental treatment 1 intervention
Group B: Placebo + standard of carePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog13)
The ADAS-cog13 is a brief battery of cognitive tests that assesses learning and memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation. The ADAS-Cog is an in-person examiner-administered, structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The ADAS-cog13 scale is scored from 0-85, with higher scores indicating a worse outcome.
Time frame
This test will be done prior to the start of treatment and at the end of treatment at 52 weeksSecondary outcomes
1
Clinical Dementia Rating scale Sum of Boxes (CDR-SB)
The CDR-SB describes five degrees of impairment in performance on each of six categories of cognitive functioning including memory, orientation, judgement, problem solving, community affairs, home and hobbies, and personal care. The CDR-SB scale is scored from 0-18, with higher scores indicating a worse outcome.
Time frame
This test will be done prior to the start of treatment and at the end of treatment at 52 weeks2
Mini-Mental State Exam (MMSE)
The MMSE is a brief, frequently used screening instrument for AD drug studies. The MMSE scale evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, ability to create a sentence, and to copy two overlapping pentagons. The MMSE scale is scored from 0-30, with lower scores indicating a worse outcome.
Time frame
This test will be done prior to the start of treatment and at the end of treatment at 52 weeks3
Neuropsychiatric inventory (NPI)
The NPI is a well-validated, reliable, multi-item instrument to assess psychopathology in AD based on an interview with a caregiver or qualified study partner (defined in this study as having direct contact 10 hours/week). It evaluates both the frequency and severity of delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition irritability, lability, apathy, and aberrant motor behavior. The NPI scale is scored from 0-5, with lower scores indicating a worse outcome.
Time frame
This test will be done prior to the start of treatment and at the end of treatment at 52 weeks4
Alzheimer's Disease Cooperative Study - Activities of daily living (ADCS-ADL).
Based on an interview with a caregiver or qualified partner, a participant is rated on his/her ability to carry out ten complex activities of daily living. The ADCS-ADL scale is scored from 0-78, with lower scores indicating a worse outcome.
Time frame
This test will be done prior to the start of treatment and at the end of treatment at 52 weeksOther outcomes
1
Amyloid-PET (Vizamyl)
Vizamyl conjugated to the isotope fluoride-18 (Vizamyl - F-18) (PET probe), is radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD). This is an optional scan.
Time frame
This test will be done prior to the start of treatment and at the end of treatment at 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Saskatchewan
Lead sponsor
Center of Molecular Immunology, Cuba
Collaborator
Source ClinicalTrials.gov
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