Evaluating the Safety, Tolerability and Efficacy of SYN120 in Parkinsonís Disease Dementia
Therapeutic Pipeline Program, 2014
Cognitive impairments ó common in Parkinsonís disease ó are associated with an imbalance in neurotransmitters (substances that allow nerve cells to communicate with one another) such as serotonin. Drugs that block certain types of serotonin receptors have been shown to improve cognition in studies, but no medications are currently FDA-approved with this mechanism of action. Biotie Therapies is developing SYN120 as an orally administered drug that blocks two serotonin receptors in the brain (5-HT6 and 5HT2a) to treat Alzheimerís disease and Parkinsonís disease.
This study seeks to determine if SYN120 is safe and tolerable and can improve cognition in Parkinsonís disease patients with dementia.
This is a Phase IIa, multicenter, randomized, double-blind, placebo-controlled, two-arm, 16-week study in Parkinsonís disease dementia patients taking a cholinesterase inhibitor. This includes a screening period of up to six weeks, a 16‑week treatment period and a two-week safety follow-up period. Eligible volunteers will be randomized to receive placebo or SYN120. Participants will return for evaluation at the study site at weeks four, eight and 16.
Impact on Diagnosis/Treatment of Parkinsonís Disease:
An effective therapy for cognitive dysfunction and dementia in Parkinsonís disease would greatly improve quality of life for patients and their loved ones.
Next Steps for Development:
Assuming this pilot study is positive, the next step will be to conduct a six-month dose-finding study (Phase IIb) comparing three to four doses of SYN120 to placebo in order to identify the optimal dose(s). At least one six-month, Phase III study comparing the optimal SYN120 dose to placebo would then be needed in order to request approval from the U.S. Food and Drug Administration.
Trial Phase: IIa
INTERIM PROGRESS REPORT
This study is recruiting volunteers. Learn more at†https://foxtrialfinder.michaeljfox.org/trial/3985/.
Vice President of Clinical Development at Biotie Therapies, Inc.
Location: South San Francisco, California, United States