CTIS2023-508306-15-00招募中1 期
A Phase 3 Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of AR1001 over 52 Weeks in Participants with Early Alzheimer’s Disease. - AR1001-ADP3-US01
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,188
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Male or female participants aged 55 to 85 years of age inclusive at the time of signing the informed consent form, 10. Participants who have one (or more) identified adult study partner(s) who, in the opinion of the Investigator, has a personal contact of a minimum of 5 days a week with the participant and are able to report knowledgably about the participant’s cognition, function, behavior, safety and compliance with the protocol. The informant/care partner must be available by phone to provide information to the Investigator and study staff about the participant as well as agree to attend in-person clinic visits that require partner input for scale completion. The informant/care partner must be literate and provide informed consent and should be available for the duration of the study. The same informant/care partner is required to be consistent across all study visits except under rare, unavoidable circumstances (e.g., unexpected informant health crisis) that are approved by the Investigator and Sponsor., 2. Mild cognitive impairment or mild dementia consistent with AD defined by stages 3 to 4 according to the National Institute on Aging and Alzheimer’s Association (NIA-AA) at Screening, 3. Participants with a history of subjective cognitive and memory decline with onset within 5 years before Screening, confirmed by study partner., 4. Participants who have a MMSE score greater than or equal to 20, 5. Participants with a CDR global rating of 0.5 or 1, 6. Participants with a Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score based on the Delayed Memory Index (DMI) score less than or equal to 85., 7. If an historic magnetic resonance imaging (MRI) is available, findings must exclude other causes of dementia, 8. Positive biomarker for brain amyloid pathology as indicated by assessment of at least one of the following: a. Current or historical CSF assessment with CE marked and FDA cleared assays. b. Historical amyloid positron emission tomography (PET) assessment confirmed by the Sponsor and/or Designee., 9. Participants and caregiver(s) who can sign an informed consent to participate in the study. Participants are expected to have the capacity to consent to study participation. Investigators will assess and confirm participants’ capacity to consent/assent.
排除标准
- •1. Participants who are female and are either pregnant, nursing, or of childbearing potential and not practicing acceptable effective contraception, 10. Participants with any of the following: a. Elevation (>2.5x upper limit of normal [ULN]) of AST (aspartate aminotransferase), ALT (alanine transaminase), or total bilirubin (unless known prior history of Gilbert’s syndrome). b. Deficiency (< lower limit of normal [LLN]) of Vitamin B12. c. Known history of HIV (human immunodeficiency virus) positivity or positive test for HIV 1/2 at screening. d. Known history of hepatitis C virus (HCV) or positive test for HCV antibody (HCV Ab) at screening (unless negative on confirmatory polymerase chain reaction [PCR] test). e. Positive test for hepatitis B surface antigen (HBsAg). f. Known history of neurosyphilis or positive test for rapid plasma regain (RPR) at screening., 11. Participants who have history of cancer or malignant tumor within 5 years prior to screening with the exception of: a. Basal or squamous cell carcinoma of the skin or cervical dysplasia, which has been adequately treated. b. In situ Grade 1 cervical cancer, fully treated at least 2 years prior to screening, and without recurrence. c. Prostate cancer, confined to the prostate gland, which has been adequately treated (e.g., surgery and/or radiation, or watchful waiting) with normal or low and stable prostate-specific antigen (PSA) levels for 2 years prior to Screening. d. Adequately treated non-metastatic breast cancer., 12. Participants who, in the opinion of the Investigator have an inadequately treated thyroid disorder., 13. Participants with inherited degenerative retinal disease, 14. Participants who have an undiagnosed or uncontrolled seizure disorder (and/or an epileptic syndrome), which has or could lead to cognitive impairment either from repeated seizures or the medications used to control the seizure disorder., 15. Participants who are being treated, or likely to require treatment during the study, with any medications prohibited by the study protocol, 16. Participants who have participated in any investigational drug or device trial within the previous 30 days or 5 half-lives of an investigational drug at Screening, whichever is longer., 17. Participants taking an oral cholinesterase inhibitor and/or memantine not on a stable dose for at least 3 months prior to screening. Treatment and dosing should remain stable, with no changes throughout the trial., 18. Participants who have been and/or are currently being treated with anti-amyloid, anti-tau, or any other investigational therapies for AD, 19. Participants who currently take any other PDE5 inhibitors (e.g., sildenafil), 2. Participants who have signs of significant ongoing delirium which may raise doubts about participant’s competence that would potentially interfere with study assessments, 20. Participants who are currently receiving (or unable to stop use for at least 14 days [2 weeks] prior to receiving the first dose of the AR1001 and throughout the study) prescription or nonprescription medications or other products known to be potent inhibitors or inducers of cytochrome P450 isozyme 3A4 (CYP3A4)., 21. Alcohol or substance use disorder within the past 5 years according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5), 22. Participants who have previously participated in a clinical trial with AR1001, 23. Participants, in the opinion of the Investigator, who are unsuitable to participate in
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