跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2022-002326-27-CZ
EUCTR2022-002326-27-CZ进行中（未招募）1 期

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF CT1812 IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE - SHINE

Cognition Therapeutics, Inc.0 个研究点目标入组 144 人开始时间: 2022年10月11日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
144
研究概览入排标准研究者记录与标识符相似试验

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

性别
All

入选标准

  • •Participants may be included in the study only if they meet all of the following criteria:
  • •1) Men, and women of non-childbearing potential, 50-85 years of age inclusively, with a diagnosis of mild to moderate Alzheimer’s disease according to the 2011 NIA-AA criteria and at least a 6 month decline in cognitive function documented in the medical record.
  • •i) Non-childbearing potential for women is defined as postmenopausal (last natural menses greater than 24 months) or undergone a documented bilateral tubal ligation or hysterectomy. If last natural menses less than 24 months, a serum FSH value confirming post-menopausal status can be employed.
  • •ii) 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 last dose 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) Diagnostic confirmation by amyloid PET with florbetaben or another approved amyloid PET ligand. Previous amyloid imaging study with a positive result will be accepted. If none is available, then amyloid PET will be conducted during screening. Diagnostic confirmation by a CSF sample collected at the screening visit lumbar puncture in place of amyloid PET will also be acceptable. Inclusion via CSF samples requires: low abeta 42 (abeta 42<667 ng/L)
  • •OR low abeta 42/40 ratio (abeta 42/40 ratio x 10 < 0.72) AND either increased total-tau (total-tau > 374 ng/L) OR increased phospho-tau (phospho-tau> 78 ng/L).
  • •3) 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 4). An historical MRI, up to 1 year prior to screening, may be used as long as there is no history of intervening neurologic disease or clinical events (such as a stroke, head trauma etc.) and the subject is without clinical symptoms or signs
  • •suggestive of such intervening events.
  • •4) MMSE 18-26 inclusive.
  • •5) No active depression and a GDS =6 (see exclusion criteria number 6).
  • •6) Modified Hachinski =4.
  • •7) Formal education of eight or more years.
  • •8) Subjects must have a caregiver/ study partner who in the opinion of the site principal investigator, has contact with the study subject for a sufficient number of hours per week to provide informative responses on the protocol assessments, oversee the administration of study drug, and is willing and able to participate in all clinic visits and some study assessments. The caregiver/ study partner must provide written informed consent to
  • •participate in the study.
  • •9) Subjects living at home or in the community (assisted living acceptable).
  • •10) Ability to swallow CT1812 capsules.
  • •11) Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.
  • •12) Subjects must be capable of providing written informed consent to the study procedures
  • •and for use of protected health information [Health Insurance Portability and Accountability
  • •Act (HIPAA), if applicable]. Written informed consent also shall be obtained from the
  • •responsible caregiver. All consent processes must be undertaken in the presence of a
  • •witness and prior to any study procedures.
  • •13) Must consent to apolipoprotein E (ApoE) genotyping for data analysi

排除标准

  • •Participants will be excluded from the study if any of the following conditions apply:
  • •1) Hospitalization (except for planned procedures) or change of chronic concomitant medication within one month prior to screening.
  • •2) Subjects living in a continuous care nursing facility.
  • •3) Contraindications to the MRI examination for any reason.
  • •4) Screening MRI (or historical MRI, if applicable) of the brain indicative of significant abnormality, including, but not limited to, 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). If a small incidental meningioma is observed, the medical monitor may be
  • •contacted to discuss eligibility.
  • •5) Clinical or laboratory findings consistent with:
  • •a) Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington’s disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
  • •b) Other neurodegenerative condition (Parkinson’s disease, amyotrophic lateral sclerosis, etc.).
  • •c) Seizure disorder.
  • •d) Other infectious, metabolic or systemic diseases affecting the central nervous system
  • •(syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other
  • •laboratory values etc.).
  • •6) A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder.
  • •Subjects with depressive symptoms successfully managed by a stable dose of an
  • •antidepressant are allowed entry.
  • •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, alkaline phosphatase > 1.5 ULN, lactate dehydrogenase (LDH)
  • •> 1.5 x ULN).
  • •b) Respiratory insufficiency.
  • •c) Renal insufficiency eGFR < 50 mL/min based on the CKD-EPI formula, as calculated by
  • •the central laboratory.
  • •d) Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within six months before screening).
  • •e) Bradycardia (<50/min.) or tachycardia (>100/min.).
  • •f) 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).
  • •g) Uncontrolled diabetes defined by HbA1c >7.5 in patients with diabetes, Only those subjects with known diabetes are required to get a HbA1c at screen.
  • •8) History of cancer within 3 years of screening with the exception of fully excised nonmelanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6
  • •9) Seropositive for human immunodeficiency virus (HIV).
  • •10) History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen [HbsAg] or anti-hepatitis C [HCV] antibody).
  • •11) Clinically significant abnormalities in screening laboratory tests, including:
  • •d) Hematocrit less than 35% for males and less than 32% for females, absolute neutrophil cell count of 1500/uL (with the exception of a documented history of a chronic benign neutropenia), or platelet cell count of <120,000/uL; INR >1.4 or other coagulopathy,
  • •confirmed by repeat assessment of:
  • •i) Hematocrit.
  • •ii) Neutrophil count.
  • •iii) Platelet count.
  • •12) Disability that may prevent the subject from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.).
  • •13) Within 4 weeks of screening visit or dur

研究者

相似试验

进行中（未招募）
1 期
Study to test COR-101 in hospitalized patients with moderate to severe Covid-19
EUCTR2020-005952-39-DECORAT Therapeutics GmbH261
进行中（未招募）
不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN CONTROLLED RELEASE FORMULATION AS ADJUNCTIVE THERAPY IN ADULTS WITH PARTIAL ONSET SEIZURES - PROTOCOL A0081194Adjunctive (add on) therapy for adult subjects with partial onset seizures with or without secondary generalization.MedDRA version: 14.1Level: LLTClassification code 10048674Term: Partial seizures with secondary generalizationSystem Organ Class: 10029205 - Nervous system disorders
EUCTR2010-019035-35-BGPfizer Inc. 235 East 42nd Street, New York, NY 10017333
进行中（未招募）
1 期
MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF NICOTINAMIDE IN PATIENTS WITH FRIEDREICHS ATAXIA.Friedreich Ataxia
EUCTR2017-002163-17-ESRWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty225
未知
不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PAHSE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE A DAY, TAK-375 (RAMELTEON) TABLET FOR SUBLINGUAL ADMINISTRATION (TAK-375SL TABLET) 0.1, 04, AND 0.8 MG AS ADJUNCTIVE THERAPY IN THE TREATMENT O ACUTE DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR 1 DISORDER IN ADULT SUBJECTS
PER-123-12TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
进行中（未招募）
不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITISCP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.MedDRA version: 9.1Level: LLTClassification code 10045365Term: Ulcerative colitis
EUCTR2008-004564-40-CZPfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK200