Parkinson's Disease Dementia (PDD)Phase 2SYNAPSENCT02258152
SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)
A Phase 2 study testing SYN120 in people with Parkinson's Disease Dementia (PDD), run by Biotie Therapies Inc. at 20 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson's Disease Dementia (PDD)
- What is being tested?
- SYN120
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 20 sitesUnited States
- Study dates
- 22 Dec 2014to 3 Oct 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's Disease Dementia
- Patient has a routine caregiver
- Taking a stable cholinesterase inhibitor.
- Patient has a Montreal Cognitive Assessment (MoCA) 10-23 inclusive
Who cannot join
- 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 locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Augusta University
Augusta, Georgia, 29847
Department of Neurology, University of Maryland Parkinson's Disease & Movement Disorder Center
Baltimore, Maryland, 21201
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Parkinson's Disease & Movement Disorder Center of Boca Raton
Boca Raton, Florida, 33486
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
Duke University
Durham, North Carolina, 27705
Struthers Parkinson's Center
Golden Valley, Minnesota, 55427
Baylor Univeristy
Houston, Texas, 77030
Houston Methodist Neurological Institute/Movement Disorders Clinic
Houston, Texas, 77030
University of Iowa, Carver College of Medicine
Iowa City, Iowa, 52245
Parkinson's Disease & Movement Disorder Center, University of Kansas Medical Center
Kansas City, Kansas, 66016
UC San Diego
La Jolla, California, 92037
Parkinson's Disease Movement Disorder Center
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Atlantic Neuroscience Institute
Summit, New Jersey, 07901
Banner Sun Health Research Institute
Sun City, Arizona, 85351
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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)
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.
Read the detailed 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).
- Conditions
- Parkinson's Disease Dementia (PDD)
- Being tested
- SYN120, Placebo
- Keywords
- PDD, Parkinson's Disease Dementia, patients taking a cholinesterase inhibitor.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYN120Drug
SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).
PlaceboDrug
Placebo QD
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| SYN120 | Experimental | Not described Receives: Drug: SYN120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
To access the effect of SYN-120 for Continuity of Attention, a measure which reflects the ability to sustain attention and avoid error The Cognitive Drug Research Computerized Cognition Battery is a computerized neuropsychological test battery to assess cognitive tasks based on measures of Vigilance (1 - 180 seconds) and Choice Reaction Time (1 - 120 seconds). The stimuli are presented on a computer screen and the subjects respond by pressing either a "Yes" or "No" on a response box. It is a time measured test.
The ability to keep mind on a single task over time. COA is calculated as (VIGACC*0.45) + (CRTACC*0.5) - where VIGACC is digit vigilance accuracy, CRTACC is choice reaction time accuracy. Higher COA scores represent greater sustained attention and avoidance of errors.
Measured: up to Week 16
Secondary outcomes (1)
To Assess the Effects of SYN120 on Cognitive Drug Research Computerized Cognition Battery (CDR) Quality of Episodic Memory (QEM)
To access the effects of SYN120 for Quality of Episodic Memory. QEM measures the ability to store, hold, and retrieve information of an episodic nature. The stimuli are presented on a computer screen and the subjects respond by pressing either a "Yes" or "No" on a response box. It is a time measured test.
Quality of Episodic Memory is calculated as (DRECOACC + DRECNACC - 100) + (DPICOACC + DPICNACC - 100) +((IRCL - IRCLERR)*100 / 15) + ((DRCL - DRCLERR)*100 / 15), where DRECOACC is Word Recognition original stimuli accuracy (1 - 120 seconds), DRECNACC is word recognition new stimuli accuracy, DPICOACC is Picture Recognition original stimuli accuracy (1 - 120.5 seconds), DPICNACC is picture recognition new stimuli accuracy, IRCL is Immediate Word Recall (1 - 120.5 seconds), IRCLERR is immediate word recall errors, DRCL is Delayed Word Recall (1 - 120.5 seconds), and DRCLERR is delayed word recall errors. Higher QEM scores greater ability to retain memory.
Measured: up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study start22 Dec 2014
- Primary completion3 Oct 2017
- Study completion3 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease Dementia (PDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotie Therapies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Massachusetts General Hospital, Acorda Therapeutics
- Responsible party
- Sponsor
- Investigators
- Christopher Kenney, Study director, Acorda Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258152
- Sponsor's protocol ID
- SYN120-CL03
- Acronym
- SYNAPSE
- Status last verified
- Apr 2019
- First submitted
- 3 Oct 2014
- Last updated
- 19 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 37532622
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02258152
- Acronym / sponsor ID
- SYNAPSE / SYN120-CL03
- Conditions
- Parkinson's Disease Dementia (PDD)
- Keywords
- PDD, Parkinson's Disease Dementia, patients taking a cholinesterase inhibitor.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Biotie Therapies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Massachusetts General Hospital, Acorda Therapeutics
- Study start
- 22 Dec 2014 (actual)
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Posted 19 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| SYN120 | Experimental | Drug: SYN120 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parkinson's Disease Dementia
- Patient has a routine caregiver
- Taking a stable cholinesterase inhibitor.
- Patient has a Montreal Cognitive Assessment (MoCA) 10-23 inclusive
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYN120SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance). | Drug | SYN120 |
| PlaceboPlacebo QD | Drug | Placebo |
Primary outcome
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
To access the effect of SYN-120 for Continuity of Attention, a measure which reflects the ability to sustain attention and avoid error The Cognitive Drug Research Computerized Cognition Battery is a computerized neuropsychological test battery to assess cognitive tasks based on measures of Vigilance (1 - 180 seconds) and Choice Reaction Time (1 - 120 seconds). The stimuli are presented on a computer screen and the subjects respond by pressing either a "Yes" or "No" on a response box. It is a time measured test. The ability to keep mind on a single task over time. COA is calculated as (VIGACC*0.45) + (CRTACC*0.5) - where VIGACC is digit vigilance accuracy, CRTACC is choice reaction time accuracy. Higher COA scores represent greater sustained attention and avoidance of errors.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37532622Fernandez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Kenney study director
Acorda Therapeutics
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYN120 in people with Parkinson's Disease Dementia (PDD), run by Biotie Therapies Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02258152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.