A Single-arm, Open-label, Expanded Access Program to Provide 100 mg CT1812 (Zervimesine) and to Collect Long-term Safety and Efficacy Data in Participants With Mild-to-moderate Dementia With Lewy Bodies (DLB).

Cognition Therapeutics16 个研究点分布在 1 个国家开始时间: 2025年5月8日最近更新: 2026年5月28日

试验速览

阶段: 不适用
状态: No Longer Available
发起方
试验地点: 16

研究概览入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a multi-center, open label, expanded access program (EAP) that will provide 100 mg CT1812 for up to one year to participants with mild-to-moderate DLB.

详细描述

Participants will be screened for eligibility by physical, laboratory, and select psychometric and neurologic assessments. Participants, after having met all inclusion criteria, and none of the exclusion criteria, will be enrolled. The first dose will be taken in the clinic. Participants and their caregivers/study partner will have a study visit clinic for repeat psychometric/neurologic testing, safety procedures and lab sample collection. Each participant and caregiver/study partner will participate in a screening period of up to 7 days, followed by an open label treatment period of 720 (± 4 days) days and a follow up phone call at day 750 (± 4 days) for a maximum of 757 days of study participation including screening.

研究设计

研究类型: Expanded Access

入排标准

年龄范围: 50 Years 至 86 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Participants must meet either one of the following criteria:
•Randomized participant in protocol COG1201 and completed the study or
•Referred by their treating physician to a participating COG1202 study site with a confirmed diagnosis of probable DLB, provide evidence of a historical MRI (within last 3 months) or CT-Scan (within last 3 months), a baseline Mini Mental Status Examination score (MMSE) of 18 - 27 inclusive and be approved by Sponsor
•Participants must have caregiver(s) / study partner who in the opinion of the site principal investigator, has contact with the study participant for a sufficient number of hours per week to provide informative responses on the protocol assessments, oversee the administration of study drug, and willing and able to participate in study visits and some study assessments. The caregiver/ study partner must also provide informed consent to participate in the study.
•Men or women 50- 86 years of age (inclusive).
•Must have had no clinically relevant findings, other than change for progression of DLB, on historical MRI or CT scan.
•In the opinion of the investigator, must be able to complete all protocol evaluations.

排除标准

•If enrolled in the previous CT1812 clinical trial for DLB (COG1201), did not complete the clinical trial, or had an adverse event that could cause an undue risk, or progressed to severe DLB and cannot complete study assessments.
•Any neurological condition that may be contributing to cognitive impairment and beyond those caused by the participant's DLB.
•History of cancer within 3 years of screening with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months based on imaging or Prostate-Specific Antigen (PSA) levels.
•Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.
•Any condition, which in the opinion of the investigator or the sponsor makes the participant unsuitable for inclusion.
•No access to a Primary Care Physician, inability or unwillingness to have lab sample collection completed per protocol.

研究者

发起方

Cognition Therapeutics

申办方类型

Industry

责任方

Sponsor

研究点 (16)

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