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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zervimesine | Drug | 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 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 the entire study. |
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Inclusion Criteria:
Participants must meet either one of the following criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Caggiano, PHD | Cognition Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | United States | ||
| Stanford Neuroscience Heath Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28592453 | Background | McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz JB, Lewis S, Lippa C, Lunde A, Masellis M, Masliah E, McLean P, Mollenhauer B, Montine TJ, Moreno E, Mori E, Murray M, O'Brien JT, Orimo S, Postuma RB, Ramaswamy S, Ross OA, Salmon DP, Singleton A, Taylor A, Thomas A, Tiraboschi P, Toledo JB, Trojanowski JQ, Tsuang D, Walker Z, Yamada M, Kosaka K. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jul 4;89(1):88-100. doi: 10.1212/WNL.0000000000004058. Epub 2017 Jun 7. |
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| ID | Term |
|---|---|
| D020961 | Lewy Body Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Palo Alto |
| California |
| 94304 |
| United States |
| University of Colorado Denver - Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| University of Miami - Department of Neurology | Boca Raton | Florida | 33433 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Ohio State University Wexner Medical Center (OSUWMC) | Columbus | Ohio | 43210 | United States |
| Summit Headlands LLC | Portland | Oregon | 97210 | United States |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |