EUCTR2018-000163-89-SE进行中（未招募）1 期
A Pilot Study to Evaluate the Effect of CT1812 Treatment on Aß Oligomer Displacement into CSF in Subjects with Mild to Moderate Alzheimer's Disease Followed by a Six-Month Open Label Extension of a Single Daily Dose of CT1812
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Men, and women of non-childbearing potential, 50-85 years of age inclusively, with a diagnosis of mild to moderate Probable Alzheimer’s Disease Dementia according to the 2011 NIA-AA criteria and at least a 6 month decline in cognitive function documented in the medical record.
- •a.Non-childbearing potential for women is defined as postmenopausal [last natural menses greater than 24 months; in women under age 55, menopausal status will be documented with serum follicle stimulating hormone (FSH) test] or undergone a documented bilateral tubal ligation or hysterectomy
- •b.Male participants who are sexually active with a woman of child-bearing potential must agree to use condoms during the trial and for 3 months after participation, unless the woman is using an acceptable means of birth control. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of: intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap
- •2.Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer’s disease and without findings of significant exclusionary abnormalities (see exclusion criteria, number
- •3.MMSE 18-26 inclusive. Subjects must, in the opinion of the investigator, be able to comply with study procedures and must understand the consent process. The investigator will use his or her clinical judgment in conjunction with the cognitive screening assessments to determine whether the subject meets these criteria in a manner that is consistent with local clinical practice and standards. Subjects with borderline low MMSE at screening may undergo repeat MMSE administration if extenuating circumstances were present at original assessment.
- •4.A positive amyloid scan (florbetaben F18, florbetapir F18, or flutametamol F18) at screening or within prior 12 months, as read by the certified, site-designated PET scan reader.
- •5.Must consent to apolipoprotein E (ApoE) genotyping
- •6.Subjects must have a caregiver or study partner who can participate in all clinic visits.
- •7.Patients living at home or in the community (assisted living acceptable)
- •8.Able to swallow CT1812 capsules.
- •9.Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.
- •10.Subjects must be capable of providing either written informed consent to the study procedures and for use of protected health information [Health Insurance Portability and Accountability Act (HIPAA) Authorization, if applicable]. Written informed consent also shall be obtained from the responsible caregiver or study partner. All consent processes must be undertaken in the presence of a witness and prior to any study procedures.
- •11.Subjects shall be generally healthy with mobility (ambulatory or ambulatory-aided, i.e., walker or cane), vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures.
- •12.Must be able to complete all screening evaluations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1 Hospitalization or change of chronic concomitant medication within one month prior to screening
- •2 Patients living in a continuous care nursing facility
- •3 Screening MRI of the brain indicative of significant abnormality, inter alia, prior hemorrhage or infarct >1 cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma)
- •4 Clinical or laboratory findings consistent with:
- •a Other primary degenerative dementia
- •b Other neurodegenerative condition
- •c Seizure disorder; or
- •d Other infectious, metabolic or systemic diseases affecting the central nervous system
- •5 A current DSM-V diagnosis that would interfere with the subject’s ability to participate in the study
- •6 Any prior history of suicidal thoughts or behavior that are believed by the investigator to represent a current safety risk
- •7 Clinically significant, advanced or unstable disease that may interfere with outcome evaluations, such as:
- •a Chronic liver disease, liver function test abnormalities or other signs of hepatic insufficiency (ALT, AST, > 1.5 ULN);
- •b Respiratory insufficiency;
- •c Renal insufficiency, defined as eGFR < 40 mL/min based on the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula, Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within six months before screening)
- •d Bradycardia (<50 beats/min.) or tachycardia (>100 beats/min.)
- •e Poorly managed hypertension (systolic >160 mm Hg and/or diastolic >95 mm Hg) or hypotension (systolic <90 mm Hg and/or diastolic <60 mm Hg); or
- •f Uncontrolled diabetes defined by HbA1c >7.5
- •8 History of cancer within 3 years of screening exception: fully excised non-melanoma skin cancers or non-metastatic prostate cancer (stable for at least 6 months)
- •9 History of acute/chronic hepatitis B or C and/or carriers of hepatitis B
- •10 Clinically significant abnormalities in screening laboratory tests, including:
- •a hematocrit <35% for males and < 32% for females,
- •b platelet cell count of < 120,000/uL, or
- •c INR >1.4 or other coagulopathy, confirmed by repeat analysis
- •d lymphocyte count less than 1200/ul
- •11 Disability that may prevent the patient from completing all study requirements
- •12 Women who are of childbearing potential
- •13 Within 4 weeks of screening visit or during the course of the study, concurrent treatment with antipsychotic agents, antiepileptics, centrally active anti-hypertensive drugs (e.g., clonidine, l-methyl dopa, guanidine, guanfacine, etc.), sedatives, opioids, mood stabilizers (e.g., valproate, lithium); or benzodiazepines, exceptions:
- •a benzodiazepines must not be administered within 5 half-lives of cognitive testing;
- •b administration of selective serotonin re-uptake inhibitors (SSRI) may be continued if stable for 60 days prior to Screening;
- •c low dose lorazepam may be used for sedation prior to MRI scan for those patients requiring sedation. Max. 2 mg lorazepam may be used for the MRI scan
- •14 Any disorder that could interfere with the absorption, distribution, metabolism or excretion of drugs
- •15 Nootropic drugs except for AD meds (acetylcholinesterase inhibitors and memantine) stable for at least 30 days
- •16 Suspected or known drug or alcohol abuse, i.e. more than approximately 60 g alcohol per day indicated by elevated MCV significantly above normal value at screening
- •17 Suspected or known allergy to any components of the stud
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