A Study to Evaluate ENT-01 for the Treatment of Parkinson's Disease Dementia
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|ClinicalTrials.gov Identifier: NCT03938922|
Recruitment Status : Active, not recruiting
First Posted : May 6, 2019
Last Update Posted : July 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Dementia||Drug: Active Investigational Treatment ENT-01||Phase 1|
The study will be conducted on an out-patient basis. Each patient will have 5 visits to the clinic: a screening visit, a randomization visit, 1 followup visit, 1 end of treatment visit, and 1 end of study visit.
Patients will be allowed to adjust their dosing, based upon protocol specifications. Rescue medications will be provided to all patients to ensure they move their bowels on a regular basis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open Label Study to Evaluate Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Dementia.|
|Actual Study Start Date :||June 13, 2019|
|Estimated Primary Completion Date :||March 28, 2021|
|Estimated Study Completion Date :||May 25, 2021|
Experimental: Active Treatment
ENT-01 tablet will be taken once daily by mouth.
Drug: Active Investigational Treatment ENT-01
ENT-01 will be administered in tablet form, once daily.
- Cognition Improvement by Dementia Severity Rating Scale (DSRS) - Primary Outcome [ Time Frame: 10 weeks ]
To determine the safety and efficacy of repeated oral doses of ENT-01 in improving cognition in patients with Parkinson's disease dementia, measured by the Dementia Severity Rating Scale (DSRS).
The DSRS Test is used to track changes in cognitive status over time. Its five subscales provide additional information on specific abilities: Attention, Initiation/Perseveration, Construction, Conceptualization, and Memory.
The score ranges from 0 to 54, with 0-18 being mild, 19-36 being moderate and 37-54 being severe. Improvements would be indicated by lower scores from baseline to end of fixed dose period.
- Change from Baseline in Montreal Cognitive Assessment (MOCA) - Secondary Outcomes [ Time Frame: 10 weeks ]To determine the effect of repeated oral doses of ENT-01 in improving cognition in patients with Parkinson's disease Dementia, measured by an improvement in the Montreal Cognitive Assessment (MOCA) from baseline.
- Change from Baseline to the End of the Fixed Dose Period in Symptoms Adapted for Parkinson's Disease (SAPS-PD) - Secondary Outcomes [ Time Frame: 10 weeks ]
To determine the effect of repeated oral doses of ENT-01 in improving the frequency and/or severity of hallucinations/delusions during the Fixed Dose period over baseline in patients with Parkinson's disease Dementia.
Improvement is defined as 2.33 points or greater reduction in score from baseline on the SAPS-PD.
- Change from Baseline to the End of the Fixed Dose Period in Neuropsychiatric Inventory (NPI) and Caregiver Distress (NPI-D) - Secondary Outcomes [ Time Frame: 10 weeks ]
To determine the effect of repeated oral doses of ENT-01 in patients with Parkinson's disease Dementia, measured by an improvement in total score for behavioral impairment from baseline to the end of fixed dose for the NPI and NPI-D.
The NPI total score is calculated by adding the scores of the domains (each domain scores ranges from 0 to 144, with higher scores indicating greater behavioral impairment.
The caregiver distress scores in each of the domains are not included in the NPI total score. The caregiver distress (NPI-D) total score is calculated by adding scores of caregiver distress in each of the domains (score ranges from 0 to 5 in each domain). The NPID total score ranges from 0 to 60 with higher scores indicating greater distress.
- Change from Baseline to the End of the Fixed Dose Period in Parkinson's Disease Questionnaire-39 (PDQ-39) - Secondary Outcomes [ Time Frame: 10 weeks ]
To determine the effect of repeated oral doses of ENT-01 in patients with Parkinson's disease Dementia, measured by an improvement in behavioral impairment, cognition, and social function by having lower scores for the PDQ-39 from baseline to the end of fixed dose.
The PDQ-39 assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. Lower scores indicate better quality of life. There is a 5-point ordinal system for scoring - 0 is never, and 4 is always.
- To compare the effect of ENT-01 on motor and non-motor symptoms of Parkinson's disease including Movement Disorder Society - Unified Parkinsons' Disease Rating Scale (MDS-UPDRS). [ Time Frame: 10 weeks ]
The additional efficacy endpoints of the study are the change from baseline in each of the following tests during the Fixed Dose Period (FDP). Baseline is defined as the end of the screening period (Visit 2). Improvement is indicated by lower total scores for the MDS-UPDRS.
The standard four-part MDS-UPDRS will be administered to determine whether there is any improvement in scores during the treatment period. Motor deterioration will be assessed from Part 3 of the MDS-UPDRS, but total score will also be reported (sum of Parts 1, 2, and 3).
- To compare the effect of ENT-01 on non-motor symptoms of Parkinson's disease for skin-temperature determined Circadian rhythm and weight. [ Time Frame: 10 weeks ]The additional efficacy endpoints of the study are the changes in skin temperature using an I-button attached to a wrist band. The I-button will be worn throughout the study, from Visit 1 to Visit 5.
- To compare the effect of ENT-01 on non-motor symptoms of Parkinson's disease for weight. [ Time Frame: 10 weeks ]Body weight will be measured from Visit 1 to Visit 5.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938922
|United States, California|
|Neuro Pain Medical Center|
|Fresno, California, United States, 93710|
|United States, New Jersey|
|Evolution Research Group - Neuroscience Research Institution|
|Toms River, New Jersey, United States, 08755|
|United States, Ohio|
|Elias Research - Neurology Diagnostics Research|
|Dayton, Ohio, United States, 45459|
|Study Chair:||Michael Zasloff, MD, Ph.D||Enterin Inc.|
|Study Chair:||Denise Barbut, MD, FRCP||Enterin Inc.|