EUCTR2015-002715-15-FI进行中（未招募）1 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,340
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
入选标准
- •Pre-screening Epoch and Genetic Disclosure Follow-up inclusion criteria:
- •1. 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
- •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.
- •5. Psychological 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
- •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 assessments 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, Treatment and Follow-up Epoch inclusion criteria:
- •Participants 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 Informed consent #2;
- •respectively 65-75 after reaching the maximum of 20% in the younger
- •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 AND CDR global score of 0.
- •With two exceptions:
- •- If the RBANS delayed memory index score is between 70 and 84
排除标准
- •Pre-screening Epoch and Genetic Disclosure Follow-up exclusion criteria:
- •1. Any disability that may prevent the participants from completing all
- •study requirements.
- •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 risk.
- •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 prostrate 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
- •7. Contraindication or intolerance to MRI or PET investigations.
- •Screening, Treatment and Follow-up Epochs 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 ARIAH as
- •demonstrated by:
- •- More than four cerebral microhemorrhages regardless of their
- •anatomical location;
- •- Single area of superficial siderosis of the CNS or evidence of a prior
- •cerebral macrohemorrhage.
- •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 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 or dependence. Participants with a positive
- •drug screen not believed to be related to drug abuse or dependence, can
- •be re-screened once.
- •4. Significantly abnormal laboratory results at Screening as described in
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