Mild Alzheimer's DiseasePhase 2NCT07178678
Evaluation of the Safety and Efficacy of NeuroEPO in Subjects With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing NeuroEPO in people with Mild Alzheimer's Disease and Moderate Alzheimer's Disease, run by University of Saskatchewan at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Alzheimer's Disease, Moderate Alzheimer's Disease
- What is being tested?
- NeuroEPO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2025to Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients (or caregiver, if the patient cannot) grant consent to participate in the study by signing the informed consent form.
- Patient with caregiver is physically and mentally willing to collaborate with the investigation.
- Mini-Mental State Examination (MMSE) score between 14 and 26 (inclusive) at screening
Who cannot join
- 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.
- Use of anticoagulants, a medication to prevent harmful blood clots (warfarin, heparin or NOAC).
- Patients where coexistence of another disease or condition that may lead to significant disability (cancer, septic embolism, endocarditis, myeloproliferative disease, creatinine> 3 mg / dl (265µmol / L), hyperkalemia > 5.0 mmol / L, chronic/severe liver or kidney or heart disorders.
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- Patients with a history of hypersensitivity to rhEPO.
- Patients with known allergy to any ingredients of the product.
- Patients who present nasal irritation (sneezing) or a runny nose before starting treatment.
- Patients who present asthma attack at the beginning of the treatment.
- Patients receiving treatment with AChE-I or Memantine who are not stable for 12-weeks prior to screening.
- Patients receiving treatment with psychoactive that can compromise the clinical trial results or neuropsychological tests.
- Patients with a history of alcoholism and/or drug dependence.
- Patients with chronic rhinosinusitis.
- Have a history of abnormal nasal or sinus symptoms.
- Have prior skull fracture or abnormality (nasal defect, deviated septum).
- Have recent nasal trauma (fracture in the last 2 months).
- Have any prior sinus or nose surgery (rhinoplasty).
- Have known bleeding problem (low platelets-thrombocytopenia), recurrent nose bleeds (>3 year).
- Have acute inflammation inside the nose.
- Congenital cranial facial disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of Saskatchewan
Saskatoon, Saskatchewan, S7N5E5
C. Ron Geyer, PhD, 3069662040, clg595@mail.usask.ca
Wendy Bernhard, PhD, wlb302@mail.usask.ca
About this study
Official title: A Phase II, Blinded, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of NeuroEPO in Subjects With Mild to Moderate Alzheimer's Disease Who Are Receiving Standard of Care Treatment
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?
Read more
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
Read the detailed description
The objective of the trial will be to assess the safety and efficacy of NeuroEPO plus standard of care treatment in participants with mild to moderate AD when delivered with a cannula attached to a syringe. A previous Phase II-III clinical trial in Cuba showed excellent safety and efficacy of NeuroEPO compared to no treatment in mild to moderate AD patients. In this clinical trial, NeuroEPO was administered intranasally with an insulin syringe. In the proposed phase II clinical trial, we will assess the safety and efficacy of 0.5 mg of NeuroEPO administered intranasally using a cannula attached to a syringe while the participant is in the Kaiteki position. Participants will be divided into two cohorts, involving 60 NeuroEPO-treated, and 30 placebo-treated participants for a total of 90 participants. NeuroEPO or the placebo will be administered three times a week for 52 weeks. An updated ADAScog test (ADAScog13) will be used as the primary outcome. The ADAScog13 test will be administered along with the other cognitive tests, Global Deterioration Scale (GDS), the Clinical Dementia Rating (CDR) the Mini Mental State Examination (MMSE), Alzheimer's Disease Co-operative Study Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory Questionnaire (NPI-Q), Quality of Life in Alzheimer's Disease (QoL-AD) prior to starting treatment and one year after treatment. β-amyloid, phosphoTau, and ApoE biomarkers and the additional neuropsychological tests will be used as secondary outcomes. Labs, vitals and adverse events will be collected prior to the start of the trial, at 1, 3, 6, and 12 months to monitor for safety. Participants who consent to MRI and/or PET will be administered MRI and PET scans twice in the trial, once when the trial participant commences the trial and once when they conclude the trial. At 12 months final evaluations will be collected for cognitive tests and for those participants who consented to MRI and/or PET a second MRI and/or PET scan will be taken.
- Being tested
- NeuroEPO, Placebo
- Keywords
- Alzheimer's Disease, NeuroEPO, EPO, ADAS-cog13
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroEPODrug
0.5 mg of NeuroEPO will be administered intranasally three times a week for 52 weeks.
PlaceboDrug
250 µL of placebo will be administered to intranasally to each nostril three times a week for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NeuroEPO + standard of care | Experimental | NeuroEPO + standard of care for Alzheimer's Disease Receives: Drug: NeuroEPO |
| Placebo + standard of care | Placebo comparator | Placebo + standard of care for Alzheimer's disease Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks
Secondary outcomes (9)
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.
Measured: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks
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.
Measured: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks
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.
Measured: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks
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.
Measured: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks
Quality of Life in Alzheimer's disease (QoL-AD).
The QoL-AD scale was developed by Logsdon et al. The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1 (poor), 2 (fair), 3 (good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.
Measured: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks
Blood analysis of phosphoTau (pTau)
Measures biomarkers p-tau181 and p-tau217 in serum.
Measured: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks
whole brain volume MRI (vMRI)
Alzheimer's disease (AD) is associated with excess whole brain volume loss, and progressive cognitive impairment. This is an optional scan.
Measured: The scan will be done prior to the start of treatment and at the end of treatment at 52 weeks
Global Dementia Scale (GDS)
GDS is used as a screening tool that helps healthcare professionals assess the progression of a patient's dementia. The GDS is scored from 0-15, with higher scores indicating a worse outcome.
Measured: This test will be given prior to the start of treatment and at the end of treatment at 52 weeks.
Blood analysis of Amyloid (Aβ1-42/Aβ1-40 ratio)
Serum detection of amyloid-beta
Measured: This test will be be done prior to treatment and at the end of treatment at 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study startNov 2025 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Alzheimer's 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
- Model description
- One group will receive NeuroEPO and one group will receive a placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Center of Molecular Immunology, Cuba
- Responsible party
- Principal investigator, Andrew Kirk, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178678
- Sponsor's protocol ID
- CBIRD.NeuroEPO.20210803
- Status last verified
- Sep 2025
- First submitted
- 25 Nov 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Blinded, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of NeuroEPO in Subjects With Mild to Moderate Alzheimer's Disease Who Are Receiving Standard of Care Treatment
- ClinicalTrials.gov ID
- NCT07178678
- Acronym / sponsor ID
- CBIRD.NeuroEPO.20210803
- Keywords
- Alzheimer's Disease, NeuroEPO, EPO, ADAS-cog13
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Center of Molecular Immunology, Cuba
- Study start
- Nov 2025 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 17 Sep 2025 (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.
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
Detailed description
The objective of the trial will be to assess the safety and efficacy of NeuroEPO plus standard of care treatment in participants with mild to moderate AD when delivered with a cannula attached to a syringe. A previous Phase II-III clinical trial in Cuba showed excellent safety and efficacy of NeuroEPO compared to no treatment in mild to moderate AD patients. In this clinical trial, NeuroEPO was administered intranasally with an insulin syringe. In the proposed phase II clinical trial, we will assess the safety and efficacy of 0.5 mg of NeuroEPO administered intranasally using a cannula attached to a syringe while the participant is in the Kaiteki position. Participants will be divided into two cohorts, involving 60 NeuroEPO-treated, and 30 placebo-treated participants for a total of 90 participants. NeuroEPO or the placebo will be administered three times a week for 52 weeks. An updated ADAScog test (ADAScog13) will be used as the primary outcome. The ADAScog13 test will be administered along with the other cognitive tests, Global Deterioration Scale (GDS), the Clinical Dementia Rating (CDR) the Mini Mental State Examination (MMSE), Alzheimer's Disease Co-operative Study Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory Questionnaire (NPI-Q), Quality of Life in Alzheimer's Disease (QoL-AD) prior to starting treatment and one year after treatment. β-amyloid, phosphoTau, and ApoE biomarkers and the additional neuropsychological tests will be used as secondary outcomes. Labs, vitals and adverse events will be collected prior to the start of the trial, at 1, 3, 6, and 12 months to monitor for safety. Participants who consent to MRI and/or PET will be administered MRI and PET scans twice in the trial, once when the trial participant commences the trial and once when they conclude the trial. At 12 months final evaluations will be collected for cognitive tests and for those participants who consented to MRI and/or PET a second MRI and/or PET scan will be taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- One group will receive NeuroEPO and one group will receive a placebo.
| Arm | Type | Receives |
|---|---|---|
| NeuroEPO + standard of care | Experimental | Drug: NeuroEPONeuroEPO + standard of care for Alzheimer's Disease |
| Placebo + standard of care | Placebo comparator | Drug: PlaceboPlacebo + standard of care for Alzheimer's disease |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Patients (or caregiver, if the patient cannot) grant consent to participate in the study by signing the informed consent form.
Key exclusion criteria (21 listed)
- 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.
- Use of anticoagulants, a medication to prevent harmful blood clots (warfarin, heparin or NOAC).
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 |
|---|---|---|
| NeuroEPO0.5 mg of NeuroEPO will be administered intranasally three times a week for 52 weeks. | Drug | NeuroEPO + standard of care |
| Placebo250 µL of placebo will be administered to intranasally to each nostril three times a week for 52 weeks. | Drug | Placebo + standard of care |
Primary outcome
Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog13)
Time frame: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks
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.
9 secondary outcomes
Clinical Dementia Rating scale Sum of Boxes (CDR-SB)
Time frame: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks
Mini-Mental State Exam (MMSE)
Time frame: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks
Neuropsychiatric inventory (NPI)
Time frame: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks
Alzheimer's Disease Cooperative Study - Activities of daily living (ADCS-ADL).
Time frame: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks
Quality of Life in Alzheimer's disease (QoL-AD).
Time frame: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks
Blood analysis of phosphoTau (pTau)
Time frame: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks
whole brain volume MRI (vMRI)
Time frame: The scan will be done prior to the start of treatment and at the end of treatment at 52 weeks
Global Dementia Scale (GDS)
Time frame: This test will be given prior to the start of treatment and at the end of treatment at 52 weeks.
Blood analysis of Amyloid (Aβ1-42/Aβ1-40 ratio)
Time frame: This test will be be done prior to treatment and at the end of treatment at 52 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- 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.
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 NeuroEPO in people with Mild Alzheimer's Disease and Moderate Alzheimer's Disease, run by University of Saskatchewan at 1 site in Canada.
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 7 inclusion and 21 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: opening soon, as of the sponsor's last update on 17 Sep 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog13) (time frame: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks). 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 17 Sep 2025.