A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Effects Of Sage-718 In Parkinson’S Disease Cognitive Impairment
Posted Date: Sep 14, 2022
- Investigator: Andrew Duker
- Specialties: Movement Disorders, Neurology, Parkinson's Disease
- Type of Study: Drug
Precedent is a randomized, double-blind, placebo-controlled study to evaluate the effects of SAGE-718 in Parkinson's Disease Cognitive Impairment. This study will include approximately 30 sites in the United States. The duration of participation for each participant is estimated to be up to 14 weeks, including 3-week Screening Period, 1-week Baseline Period, 6-week Treatment Period, and 4-week Follow-up Period. Eligible participants with a confirmed diagnosis of idiopathic Parkinson's Disease and Mild Cognitive Impairment will receive a 1.2 mg dose of SAGE-718 or placebo daily for 6 weeks.
Criteria:
Eligible Participants Will Be Capable Of Providing Informed Consent; Between The Ages Of 50 And 75 Years; Diagnosed With Parkinson's Disease And Mild Cognitive Impairment; Score Between 18 And 25 On The Moca; Meet Criteria For Modified Hoehn And Yahr Stage I To Iii; Have Stable Motor Symptoms And Concomitant Medications For At Least 4 Weeks; Use An Acceptable Highly Effective Method Of Contraception; Refrain From Drugs Of Abuse For The Duration Of The Study And Alcohol During The 48 Hours Preceding Each Study Visit. Exclusion Criteria Include Participation In A Previous Clinical Trial Of Sage-718, A Gene Therapy Study, Or Received Study Treatment In Any Other Drug, Biologic, Or Device Trial With 180 Days; Have Clinically Significant Comorbid Medical Conditions, A Chronic Condition That Is Unstable, Or Are Taking Any Concomitant Medications That Make The Participant Unsuitable For Inclusion; Have A Diagnosis Of Dementia Or Any Other Parkinsonism Other Than Pd; Experience Motor Symptoms That Will Interfere With The Completion Of Study Procedures; Have An Ongoing Cns Condition Other Than Pd; Have Significant Psychotic Symptoms; Have A History Of Brain Surgery, Dbs, Or Hospitalization Due To A Brain Injury; Have Clinically Relevant Intracranial Abnormality; Be Receiving Prohibitive Medications; Have An Alcohol Or Drug Use Disorder; Have A History Of Seizures Or Epilepsy; Have Suicidality; Have Clinically Significant Ecg Findings Or Vitals; Have Significant Hepatic, Renal, Cardiovascular, Pulmonary, Gastrointestinal; Hematological, Immunologic, Ophthalmologic, Metabolic, Or Oncological Disease; Have Hiv Or Hepatitis B Or C; Have A Positive Pregnancy Test, Be Lactating, Or Intend To Breastfeed During The Study; Or Be Investigative Site Personnel, Sponsor Personnel, Or An Immediate Family Member.
Keywords:
Parkinson's Disease, Mild Cognitive Impairment, Neurology
For More Information:
Bobbie Lee Stubbeman
513-558-0142
stubbebl@ucmail.uc.edu