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A Study to Evaluate ENT-01 for the Treatment of Parkinson’s Disease Dementia

Studies

Study First Submitted Date 2019-04-18
Study First Posted Date 2019-05-06
Last Update Posted Date 2023-06-12
Start Month Year January 15, 2024
Primary Completion Month Year June 15, 2025
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-06-12

Detailed Descriptions

Sequence: 20806767
Description 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.

Facilities

Sequence: 200819230 Sequence: 200819231 Sequence: 200819232
Name Neuro Pain Medical Center Name Evolution Research Group – Neuroscience Research Institution Name Elias Research – Neurology Diagnostics Research
City Fresno City Toms River City Dayton
State California State New Jersey State Ohio
Zip 93710 Zip 08755 Zip 45459
Country United States Country United States Country United States

Conditions

Sequence: 52388071 Sequence: 52388072
Name Parkinson Disease Name Dementia
Downcase Name parkinson disease Downcase Name dementia

Id Information

Sequence: 40312959
Id Source org_study_id
Id Value ENT-01-1b-19-01

Countries

Sequence: 42735958
Name United States
Removed False

Design Groups

Sequence: 55834540
Group Type Experimental
Title Active Treatment
Description ENT-01 tablet will be taken once daily by mouth.

Interventions

Sequence: 52698045
Intervention Type Drug
Name Active Investigational Treatment ENT-01
Description ENT-01 will be administered in tablet form, once daily.

Other Names:

ENT-01

Keywords

Sequence: 80164005 Sequence: 80164006
Name PDD Name parkinson's disease-related dementia
Downcase Name pdd Downcase Name parkinson's disease-related dementia

Design Outcomes

Sequence: 178180352 Sequence: 178180353 Sequence: 178180354 Sequence: 178180355 Sequence: 178180356 Sequence: 178180357 Sequence: 178180358 Sequence: 178180359
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other
Measure Cognition Improvement by Dementia Severity Rating Scale (DSRS) – Primary Outcome Measure Change from Baseline in Montreal Cognitive Assessment (MOCA) – Secondary Outcomes Measure Change from Baseline to the End of the Fixed Dose Period in Symptoms Adapted for Parkinson's Disease (SAPS-PD) – Secondary Outcomes Measure Change from Baseline to the End of the Fixed Dose Period in Neuropsychiatric Inventory (NPI) and Caregiver Distress (NPI-D) – Secondary Outcomes Measure Change from Baseline to the End of the Fixed Dose Period in Parkinson's Disease Questionnaire-39 (PDQ-39) – Secondary Outcomes Measure 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). Measure To compare the effect of ENT-01 on non-motor symptoms of Parkinson's disease for skin-temperature determined Circadian rhythm and weight. Measure To compare the effect of ENT-01 on non-motor symptoms of Parkinson's disease for weight.
Time Frame 10 weeks Time Frame 10 weeks Time Frame 10 weeks Time Frame 10 weeks Time Frame 10 weeks Time Frame 10 weeks Time Frame 10 weeks Time Frame 10 weeks
Description 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.

Description 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. Description 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.

Description 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.

Description 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.

Description 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).

Description 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. Description Body weight will be measured from Visit 1 to Visit 5.

Browse Conditions

Sequence: 194310712 Sequence: 194310713 Sequence: 194310714 Sequence: 194310715 Sequence: 194310716 Sequence: 194310717 Sequence: 194310718 Sequence: 194310719 Sequence: 194310720 Sequence: 194310721 Sequence: 194310722 Sequence: 194310723
Mesh Term Parkinson Disease Mesh Term Dementia Mesh Term Parkinsonian Disorders Mesh Term Basal Ganglia Diseases Mesh Term Brain Diseases Mesh Term Central Nervous System Diseases Mesh Term Nervous System Diseases Mesh Term Movement Disorders Mesh Term Synucleinopathies Mesh Term Neurodegenerative Diseases Mesh Term Neurocognitive Disorders Mesh Term Mental Disorders
Downcase Mesh Term parkinson disease Downcase Mesh Term dementia Downcase Mesh Term parkinsonian disorders Downcase Mesh Term basal ganglia diseases Downcase Mesh Term brain diseases Downcase Mesh Term central nervous system diseases Downcase Mesh Term nervous system diseases Downcase Mesh Term movement disorders Downcase Mesh Term synucleinopathies Downcase Mesh Term neurodegenerative diseases Downcase Mesh Term neurocognitive disorders Downcase Mesh Term mental disorders
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48521330
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Enterin Inc.

Overall Officials

Sequence: 29399212 Sequence: 29399213
Role Study Chair Role Study Chair
Name Michael Zasloff, MD, Ph.D Name Denise Barbut, MD, FRCP
Affiliation Enterin Inc. Affiliation Enterin Inc.

Design Group Interventions

Sequence: 68443958
Design Group Id 55834540
Intervention Id 52698045

Eligibilities

Sequence: 30890743
Gender All
Minimum Age 30 Years
Maximum Age 90 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Patients aged 30-90 years, both genders
Patients or care-giver must provide informed consent and be willing and able to comply with study procedures.
Patients must be diagnosed with Parkinson's disease defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features: rest tremor, rigidity, bradykinesia and/or akinesia, postural and gait abnormalities.
Patients must have dementia as defined by (1) decline in cognitive function and (2) functional impairment, which together in, in the opinion of the investigator, has resulted in a clinical diagnosis of dementia.
MoCA < 24 in support of a dementia diagnosis
Have a reliable and actively involved caregiver who must be able to communicate in English and be willing to comply with protocol requirements.
If on anti-parkinsonian agents, participants must be on stable dosage for at least 4 weeks prior to baseline.
If on medications enhancing cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 8 weeks prior to baseline.
If on antidepressant medications, participants must be on stable dosage for at least 4 weeks prior to baseline.
If on clozapine, pimavanserin or quetiapine to address drug-induced or disease-related psychosis, participants must be on stable dosage for 4 weeks prior to baseline.
Female patients of childbearing potential must have negative serum or urine pregnancy tests and must not be lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. A vasectomized partner will be allowed as one in conjunction with another single-barrier method.
Female patients unable to bear children must have this documented in the case report form (CRF) (i.e., tubal ligation, hysterectomy, or postmenopausal [defined as a minimum of one year since the last menstrual period]). Post-menopausal status will be confirmed by follicle stimulating hormone (FSH) in women less than 60 years of age.

Exclusion Criteria:

Patient or caregiver unable or unwilling to provide informed consent or to comply with study procedures.
Unable to withdraw proton pump inhibitors at the end of run-in period.
Unable to withdraw from anti-cholinergics at the beginning of the run-in period
Any clinically significant abnormalities on screening laboratories or physical examination requiring further evaluation or treatment.
Neurological disorder other than Parkinson's disease that in the opinion of the investigator might interfere with the conduct of the study
Females who are pregnant or breastfeeding
History of excessive alcohol use or substance abuse
Psychotic disorder was present before the diagnosis of Parkinson's disease
Patient or caregiver unable to administer daily oral dosing of study drug
Caregiver unwilling or unable to unable to complete stool diary, dispense study medication and accompany the patient to all visits
Participation in an investigational drug trial within the month prior to dosing in the present study.
A compromised gastrointestinal system which includes: Structural, metabolic, or functional GI diseases or disorders; History of major GI surgery within 30 days (a history of cholecystectomy, polypectomy, hernia repair, appendicectomy, gastric surgery for peptic ulcer and gastric banding for obesity are not exclusionary as long as they were performed more than 30 days before the screening visit. Partial or complete colectomy is exclusionary).
Review of Screening period diaries indicates either of the following: Fewer than 11 days of diary completion; More than 5 complete spontaneous bowel movements per week based upon the average Complete Spontaneous Bowel Movement (CSBM) rate reported during the Screening Period.
Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254131663
Number Of Facilities 3
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 30
Maximum Age Num 90
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 4
Number Of Other Outcomes To Measure 3

Designs

Sequence: 30636492
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 29003095
Responsible Party Type Sponsor