Phase I-B Clinical Trial of AVE8112 for Cognitive Impairment in Parkinson’s Disease

Objective/Rationale:
Cognitive impairment is a symptom seen in Parkinson’s disease (PD) patients, and some can progress to dementia. AVE8112 is a PDE4 inhibitor that was in development by the pharmaceutical company Sanofi for the treatment of cognitive impairment in Alzheimer’s disease patients and had shown promise in several pre-clinical models. The Michael J. Fox Foundation partnered with Sanofi to develop AVE8112 for the treatment of cognitive impairment in Parkinson’s patients. The goal of this study is to determine the safety and tolerability of AVE8112 in subjects with PD.

Project Description:
This study at two sites (Glendale, CA and Baltimore, MD) is to assess the safety and tolerability of an oral medication administered over 14 days.

Relevance to Diagnosis/Treatment of Parkinson’s Disease:
Cognitive impairment is common in PD patients, but at present no safe and effective therapies exist.

Anticipated Outcome:
This clinical trial is intended to establish the safety and tolerability of various doses of AVE8112 in patients with PD to enable wider exploration in a subsequent Phase II trial for the symptomatic treatment of cognitive impairment in PD patients.

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