SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)

Biotie Therapies

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease Dementia (PDD)

Treatments: Drug: SYN120; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02258152

SYN120-CL03

Details and patient eligibility

About

The purpose of this study placebo-controlled, randomized, double-blind study is to assess the safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already treated with a stable dose of a cholinesterase inhibitor.

Full description

This study includes a Screening Period of up to 6 weeks, a 16 week Treatment Period, and a 2 week Safety Follow Up Period.

Final eligibility will be determined at the Baseline Visit. Eligible patients will be randomized to receive placebo or SYN120 100 mg once a day (QD).

Enrollment: 82 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parkinson's Disease Dementia
• Patient has a routine caregiver
• Taking a stable cholinesterase inhibitor.
• Patient has a Montreal Cognitive Assessment (MoCA) 10-23 inclusive

Exclusion criteria

• History of any significant neurologic or psychiatric disease other than PD
• Any other condition or clinically significant abnormal findings that would make the patient unsuitable for the study
• Unpredictable motor fluctuations that would interfere with administering assessments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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82 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

SYN120

Experimental group

Treatment:

Drug: SYN120