An Open-label Clinical Trial Investigating the Long-term Safety of Buntanetap in Treating Participants With Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Adverse Events (AE)
研究概览
简要总结
This study will examine the long-term safety of buntanetap in participants with AD who have participated in a prior study of buntanetap in AD.
详细描述
ANVS-26001 will be a 24-month open-label safety study. Qualified participants will receive buntanetap 30 mg daily after a screening period of up to 42 days. ADAS-Cog13, ADCS-iADL, CDR, MMSE, WAIS-Coding, NPI-12, QoL-AD, CGI-S, and C-SSRS will be assessed by clinicians who have successfully completed the requisite certifications/trainings for each assessment. Each participant shall be assessed by the same clinician throughout the study. An independent Data and Safety Monitoring Board (DSMB) will assess treatment safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has participated in a prior Alzheimer's clinical trial with buntanetap.
- •Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (minimum 10 hours per week), and will accompany the participant on study visits at designated times.
- •Female participants of childbearing potential must have a negative urine pregnancy test at screening, be non-lactating, and must agree to use a highly effective method of contraception.
- •Male participants must be sterile or sexually inactive or agree not to father a child during the study and one month after the last dose of study medication and must agree to use a barrier method for contraception. Female partners of male participants must adopt a highly effective method of contraception.
- •General cognition and functional performance sufficiently preserved that the subject can provide written informed consent. Legally authorized representatives will be needed for participants whose MMSE is equal or less than 20 at screening.
- •No evidence of current suicidal ideation or previous suicide attempt in the last month as evaluated in the CSSRS.
- •Stability of permitted medications for at least 4 weeks prior to screening.
- •Adequate visual and hearing ability (physical ability to perform all assessments).
- •Good general health with no disease expected to interfere with the study.
排除标准
- •Has history of psychiatric disorder such as schizophrenia, bipolar disorder, or major depression according to the criteria of the most current version of the DSM, unless they are stable on treatment. Mild depression or history of depression that is stable on treatment with SSRI or SNRI at a stable dose is permitted.
- •Has non-AD dementia, such as vascular dementia, Lewy Body dementia, frontotemporal dementia, Parkinson's disease dementia, B12 and thyroid deficiency cause dementia.
- •History of seizure disorder, but if stable on medication is acceptable.
- •ANVS-25001 legacy participants: screening MRI of brain indicative of significant abnormality, including but not limited to, prior hemorrhage (>5 microhemorrhages) or infarct >1cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g., abcess or brain tumor such as meningioma, unless they are documented and stable).
- •Legacy participants from studies not ANVS-25001 submission of a historical MRI performed within the last year is encouraged for PI review. A screening MRI is not required.
- •History or current evidence of long QT syndrome, Fridericia's formula corrected QT (QTcF) interval equal or greater than 450 ms for men and 460 ms for women, or torsades de pointes.
- •Has bradycardia (<50 bpm) or tachycardia (>100 bpm) on the ECG at screening.
- •Has uncontrolled Type-1 or Type-2 diabetes. A participant with HbA1c levels up to 7.5% can be enrolled if the investigator believes the participant's diabetes is under control.
- •Has clinically significang renal (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <45 mL/min/BSA (body surface area) or hepatic impairment (Alkaline phosphatase (ALP) > 2.0 ULN and/or total bilirubin > 2.0 ULN).
- •Has any clinically significant abnormal laboratory values. Participants with liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) greater than twice the upper limit of normal will be excluded.
- •Is at imminent risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the Investigators. Participants must be excluded if they report suicidal ideation with intent, with or without a plan or method (e. g., positive response to Items 4 or 5 in assessment of suicidal ideation on The Columbia Suicide Severity Rating Scale (C-SSRS)) in the past 2 months, or suicidal behavior in the past 6 months.
- •Has cancer or has had a malignant tumor within the past year, except participants who underwent potentially curative therapy with no evidence of recurrence (participants with stable untreated cancer are not excluded).
- •Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version Diagnostic and Statistical Manual of Mental Disorders (DSM).
- •Participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 4 weeks prior to the start of screening, or five half-lives of the investigational drug, whichever is greater. The end of a previous investigational trial is the date the last dose of an investigational agent was taken.
- •Participants with learning disability or developmental delay.
- •Participants whom the site PI deems to be otherwise ineligible.
- •Participants with a known allergy to the investigational drug or any of its components.
- •Inactive ingredients of the investigational medicinal product:
- •Silicified Microcrystalline Cellulose Dibasic Calcium Phosphate Dihydrate
- •Stearic Acid
- •Hypromellosee (capsule shells structure)
- •Titanium dioxide (opacifier of the capsule shells)
- •Participant is currently pregnant, breast-feeding, and/or lactating.
- •Participants with uncontrolled hypertension (systolic >160mm Hg and/or diastolic >95mm Hg) or hypotension (systolic <90mm Hg and/or diastolic <60 mm Hg) and deemed medically significant by the PI.
研究组 & 干预措施
Single Arm
All participants receive buntanetap 30 mg qd
干预措施: buntanetap/posiphen (Drug)
结局指标
主要结局
Adverse Events (AE)
时间窗: 24 months of study
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention
Treatment Emergent Adverse Events (TEAE)
时间窗: 24 months of study
TEAE is an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state
Serious Adverse Events (SAE)
时间窗: 24 months of study
SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization, or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a birth defect or congenital anomaly
Safety of buntanetap
时间窗: 24 months of treatment
Safety assessments of participants with AD receiving treatment with buntanetap
次要结局
未报告次要终点