Evaluation of the Safety and Efficacy of NeuroEPO in Subjects With Mild to Moderate Alzheimer's Disease

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат NeuroEPO
  0.5 mg of NeuroEPO will be administered intranasally three times a week for 52 weeks.
• Препарат Placebo
  250 µL of placebo will be administered to intranasally to each nostril three times a week for 52 weeks.

Первичные конечные точки

• Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog13) [Срок оценки: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks]

Вторичные конечные точки (9)

• Clinical Dementia Rating scale Sum of Boxes (CDR-SB) [Срок оценки: 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) [Срок оценки: This test will be done prior to the start of treatment and at the end of treatment at 52 weeks]
• Neuropsychiatric inventory (NPI) [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: The scan will be done prior to the start of treatment and at the end of treatment at 52 weeks]
• Global Dementia Scale (GDS) [Срок оценки: 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) [Срок оценки: This test will be be done prior to treatment and at the end of treatment at 52 weeks.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• University of Saskatchewan — Saskatoon

Идентификаторы

NCT: NCT07178678 · CBIRD.NeuroEPO.20210803

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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