NL-OMON50176已完成2 期
A randomized, double-blind, placebo-controlled, two-cohort parallel group study to evaluate the efficacy of CAD106 and CNP520 in participants at risk for the onset of clinical symptoms of Alzheimer*s disease - CAPI015A2201J
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 20
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 99（—）
入选标准
- •Pre-screening Epoch and Genetic Disclosure Follow-up inclusion criteria1.
- •Written informed consent (Informed consent #1) obtained before any assessment
- •is performed, including consent to receive disclosure of their APOE genotype.
- •2. Male or female, age 60 to 75 years inclusive, at the time of signing the
- •informed consent #1 (same age restriction also applied at informed consent #2).
- •a. Once the cap of approximately 20% of total participants in the age group 60-
- •64 years is met, a restriction to this age group will apply.
- •3. Females must be considered post-menopausal and not of child bearing
- •potential. Confirmation will be obtained for those who continue on to the
- •Screening Epoch.
- •4. Mini-Mental State Examination (MMSE) total score * 24 (can be based on
- •documented result obtained i previous 3 months).
- •5. Psycholgical readiness to receive APOE genotype information based on
- •pre-disclosure rating scales:
- •a. Geriatric Depression Scale (GDS short form) total score *6.
- •If the score is between 7 and 10 (inclusive), the participant can only be
- •included based on investigator*s judgment assessing in particular the scores
- •of the questions:
- •i. Item 3: *Do you feel your life is empty?*
- •ii. Item 6: *Are you afraid that something bad is going to happen to you?*
- •iii. Item 12: *Do you feel pretty worthless the way you are now?*
- •iv. Item 14: *Do you feel your situation is hopeless?*
- •b. Six Item Subset Inventory of the STAI-AD total score *17.
- •If the score is 18 or 19, the participant can only be included based on the
- •investigator*s judgment.
- •6. Participant is fluent in, and able to read the language in which the study
- •are administered (e.g. completion of at least 6 years of regular schooling or
- •sustained employment).
- •7. Participant*s willingness to have a study partner for the Screening and
- •Treatment epoch.
- •Screening and Treatment Epoch inclusion criteriaParticipants eligible for
- •inclusion must fulfill all of the following criteria prior to randomization:
- •1. Written informed consent (Informed consent #2) for participation to the
- •Screening and Treatment Epochs (participant must still be between 60-75 years,
- •inclusive at the time of signing ICF #2; respectively 65-75 after reaching the
- •maximum of 20% in the ypunger age group 60-64).
- •2. Continue to meet all eligibility criteria from Pre-screening Epoch and
- •Genetic Disclosure Follow-up, as confirmed by the review of the medical records
- •by the Investigator.
- •3. Homozygous APOE4 genotype.
- •4. Cognitively unimpaired as defined by:
- •* At the screening visit, score of 85 or greater on the RBANS delayed memory
- •index score
- •* CDR global score of 0
- •with two exceptions:
- • If the RBANS delayed memory index score is between 70 and 84 (inclusive) AND
- •the global CDR score <= 0, the participant may be allowed to continue ONLY if
- •the Investigator judges that cognition is unimpaired following review of the
- •MCI/dementia criteria.
- • If the global CDR score <= 0.5 AND the RBANS delayed memory index score is 85
- 另有 5 项未显示
排除标准
- •Pre-screening Epoch and Genetic Disclosure Follow-up exclusion criteria1. Any
- •disability that may prevent the participants from completing all study
- •requirements (e.g., blindness, deafness, severe language difficulty).
- •2. Current medical or neurological condition that might impact cognition or
- •performance on cognitive assessments.
- •3. Advanced, severe progressive or unstable disease that may interfere with the
- •safety, tolerability and study assessments, or put the participant at special
- •4. History of malignancy of any organ system, treated or untreated, within the
- •past 60 months, regardless of whether there is evidence of local recurrence or
- •metastases. However, localized nonmalignant tumors not requiring systemic
- •chemo- or radio-therapy, localized basal or squamous cell carcinoma of the
- •skin, in-situ cervical cancer, localized vulvar carcinoma and localized
- •prostate carcinoma with no progression over the past two years are permitted.
- •5. History of hypersensitivity to any of the investigational drugs or their
- •excipients/adjuvant, or to drugs of similar chemical classes.
- •6. Indication for or current treatment with ChEIs and/or another AD treatment
- •(e.g. memantine).
- •7. Contraindication or intolerance to MRI or PET investigations.Screening and
- •Treatment Epoch exclusion criteria
- •Participants fulfilling any of the following criteria prior to randomization
- •will be excluded.
- •Participants, who fulfill one or more exclusion criteria due to a temporary
- •condition, or the use of treatment requiring a specific time window prior to
- •randomization, can be re-screened at a later stage:
- •1. Brain MRI results from the central reading showing findings unrelated to AD
- •that, in the opinion of the Investigator might be a leading cause of future
- •cognitive decline, might pose a risk to the participant, or might confound MRI
- •assessment for safety monitoring.For Cohort I (CAD 106) only, in addition,
- •evidence of ARIA-H as demonstrated by:
- •* More than four cerebral microhemorrhages (defined as diameter * 10 mm on T2*
- •sequence) regardless of their anatomical location
- •* Single area of superficial siderosis of the CNS or evidence of a prior
- •cerebral macrohemorrhage (> 10 mm diameter)
- •2. Score *yes* on item four or item five of the Suicidal Ideation Section of
- •the C-SSRS if this ideation occurred in the past six months, or *yes* on any
- •item of the Suicidal Behavior Section, except for the *Non-Suicidal
- •Self-Injurious Behavior* (item also included in the Suicidal Behavior Section)
- •if this behavior occurred in the past two years prior to screening.
- •3. A positive drug screen at Screening, if, in the Investigator*s opinion, this
- •is due to drug abuse. Participants with a positive drug screen not believed to
- •be related to drug abuse (e.g. presence of prescription drugs in urine without
- •evidence of prescription drug abuse), can be re-screened once.
- •4. Significantly abnormal laboratory results at Screening as described in
- •appendix 13.4 or meeting the exclusionary alert values specified in the
- •Laboratory Manual. If, in the opinion of the Investigator, an abnormal finding
- •is the result of a temporary condition, the laboratory test can be repeated
- •5. Clinically significant active infection which has not resolved wiothin 2
- •weeks prior to initial dosing.
- •6. Current clinically significa
研究者
相似试验
进行中（未招募）
1 期
A randomized, double-blind, placebo-controlled, two way cross-over study to assess the particle deposition and acute effects of formoterol and budesonide combination therapy (Symbicort® forte Turbohaler®) on the upper airway dimensions in COPD patients.EUCTR2009-016502-16-BEniversity Hospital Antwerp : Department Respiratory Medicine
进行中（未招募）
1 期
To evaluate the efficacy of CAD106 and CNP520 in participants at risk for the onset of Alzheimer’s diseaseMedDRA version: 18.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852Alzheimer's diseaseEUCTR2015-002715-15-NLovartis Pharma Services AG477
进行中（未招募）
1 期
Plerixafor in acute respiratory distress syndrome related to covid-19 (Phase IIb)MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestationsSevere COVID-19MedDRA version: 23.1Level: PTClassification code 10084380Term: COVID-19 pneumoniaSystem Organ Class: 10021881 - Infections and infestationsEUCTR2021-001245-13-FR4Living Biotech SAS150
进行中（未招募）
1 期
Plerixafor in acute respiratory distress syndrome related to covid-19 (Phase IIb)Severe COVID-19MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestationsMedDRA version: 23.1Level: PTClassification code 10084380Term: COVID-19 pneumoniaSystem Organ Class: 10021881 - Infections and infestationsEUCTR2021-001245-13-NL4Living Biotech SAS150
进行中（未招募）
不适用
A study to see if it is safe to give a new asthma controller drug (called fluticasone furoate) to 5 to 11 year old children with asthma.AsthmaMedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2012-000753-31-Outside-EU/EEAGlaxoSmithKline Research & Development Ltd26