SYNAPSE

CompletedPhase 2Results posted

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

SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)

Lead sponsor

Biotie Therapies Inc.

Asset

SYN120

Listed sites

Recruiting sites

Enrollment

actual

Study population

Lewy body dementia

Key I/E criteria

•Parkinson's disease dementia•MoCA 10-23•Study partner/caregiver required

Primary endpoint

•Primary Efficacy Objective of This Study is to Assess the Efficacy of SYN120

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02258152

Org study IDSYN120-CL03

Timeline

Milestones

Study first posted2014-10-07estimated

Study start2014-12-22actual

Primary completion2017-10-03actual

Study completion2017-10-03actual

Last update posted2019-04-19actual

Results first posted2019-04-19actual

Assets

Drug assets

SYN120

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Memory

Global cognition

2 endpoints

Primary/protocol endpoint

The Primary Efficacy Objective of This Study is to Assess the Efficacy of SYN120 on Cognition as Determined by the Cognitive Drug Research Computerized Cognition Battery (CDR) Continuity of Attention in Patients With Parkinson's Disease.

Time frame:up to Week 16

descriptive

Primary/registry result

Time frame:up to Week 16

descriptive

Posted result

Group	Value (mean), Seconds	Standard deviation
PlaceboScreening (1)n=38 Participants	77.04	15.56
Screening (2)n=38 Participants	80.97	13.66
Baselinen=38 Participants	80.95	11.45
Week 8n=38 Participants	78.83	17.08
Week 16n=38 Participants	81.25	12.36
Change from Week 0 to 8n=38 Participants	-1.88	16.73
Change from Week 0 to 16n=38 Participants	-0.35	10.51
SYN120Screening (1)n=34 Participants	75.61	21.39
Screening (2)n=34 Participants	80.70	16.80
Baselinen=34 Participants	80.98	13.01
Week 8n=34 Participants	77.68	19.60
Week 16n=34 Participants	79.37	15.90
Change from Week 0 to 8n=34 Participants	-3.31	12.22
Change from Week 0 to 16n=34 Participants	-3.70	12.86

Memory

2 endpoints

Secondary/protocol endpoint

To Assess the Effects of SYN120 on Cognitive Drug Research Computerized Cognition Battery (CDR) Quality of Episodic Memory (QEM)

Time frame:up to Week 16

descriptive

Secondary/registry result

To Assess the Effects of SYN120 on Cognitive Drug Research Computerized Cognition Battery (CDR) Quality of Episodic Memory (QEM)

Time frame:up to Week 16

descriptive

Posted result

Group	Value (mean), Seconds	Standard deviation
PlaceboScreening (1)n=38 Participants	107.66	55.49
Screening (2)n=38 Participants	111.98	55.62
Baselinen=38 Participants	117.70	49.68
Week 8n=38 Participants	123.58	52.03
Week 16n=38 Participants	112.43	69.50
Change from Week 0 to 8n=38 Participants	5.89	46.66
Change from Week 0 to 16n=38 Participants	-5.77	55.41
SYN120Screening (1)n=34 Participants	116.14	60.50
Screening (2)n=34 Participants	99.69	30.11
Baselinen=34 Participants	114.13	45.93
Week 8n=34 Participants	118.37	61.95
Week 16n=34 Participants	118.20	54.08
Change from Week 0 to 8n=34 Participants	4.25	49.02
Change from Week 0 to 16n=34 Participants	-0.08	45.33

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Fernandez HH, Weintraub D, Macklin E, Litvan I, Schwarzschild MA, Eberling J, Videnovic A, Kenney CJ; Parkinson Study Group SYNAPSE Investigators. Safety, tolerability, and preliminary efficacy of SYN120, a dual 5-HT6/5-HT2A antagonist, for the treatment of Parkinson disease dementia: A randomized, controlled, proof-of-concept trial. Parkinsonism Relat Disord. 2023 Sep;114:105511. doi: 10.1016/j.parkreldis.2023.105511. Epub 2023 Jul 13.
PMID37532622via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.