This is a multi-center, open label, expanded access program (EAP) that will provide 100mg CT1812 for up to one year to participants with mild-to-moderate DLB.
Participants will be screened for eligibility by physical, laboratory, psychometric and
neurologic examinations. After having met all inclusion criteria, and none of the
exclusion criteria, participants 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 360 (± 4 days) days and a follow
up visit at day 390 (± 2 days) for a maximum of 397 days of study participation including
screening.
Drug: zervimesine
Zervimesine (CT1812) was shown to be safe and well tolerated in a study of healthy
volunteers and in Phases 1 and 2 studies of participants with mild to moderate AD and
DLB. This is an open label expanded access program designed to provide access to CT1812
and to evaluate the long-term safety of CT1812 administered once daily for 12 months in
adults aged 50 to 86 who have been diagnosed with mild to moderate DLB (the targeted
clinical indication for CT1812). Participants will receive 100 mg of CT1812 once daily
for 360 days.
Other Name: CT1812
Inclusion Criteria:
1. Participants must meet either one of the following criteria:
1. Randomized participant in protocol COG1201 and completed the study or
2. Referred by their treating physician to a participating COG1202 study site with
a confirmed diagnosis of DLB, have a historical MRI or CT-Scan on file, a
baseline Mini Mental Status Examination score (MMSE) of 18 - 27 inclusive and
be approved by Sponsor.
2. 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.
3. Men or women 50- 86 years of age (inclusive).
4. Must have had no clinically relevant findings, other than change for progression of
DLB, on historical MRI or CT scan.
5. In the opinion of the investigator, must be able to complete all protocol
evaluations.
Exclusion Criteria:
1. 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.
2. Any neurological condition that may be contributing to cognitive impairment and
beyond those caused by the participant's DLB.
3. 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.
4. Clinically significant, advanced or unstable disease that may interfere with outcome
evaluations.
5. Any condition, which in the opinion of the investigator or the sponsor makes the
participant unsuitable for inclusion.
Banner Sun Health Research Institute
Sun City, Arizona, United States
Investigator: David Shprecher, DO
Theresa Devins, DrPH, MS
888-745-1050
clinicaltrials@cogrx.com
Anthony Caggiano, PHD, Study Director
Cognition Therapeutics Inc.