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

NCT03938922 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: ENT-01-1b-19-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

This study will be conducted as a multi-center, open label study in the US. There will be 40 patient to receive the active investigational product.

Conditions

Parkinson Disease; Dementia

Keywords

PDD; parkinson's disease-related dementia

Outcome Measures

Primary Outcomes (1)

• Cognition Improvement by Dementia Severity Rating Scale (DSRS) - Primary Outcome

  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.

  10 weeks

Secondary Outcomes (4)

• Change from Baseline in Montreal Cognitive Assessment (MOCA) - Secondary Outcomes

  10 weeks

• Change from Baseline to the End of the Fixed Dose Period in Symptoms Adapted for Parkinson's Disease (SAPS-PD) - Secondary Outcomes

  10 weeks

• Change from Baseline to the End of the Fixed Dose Period in Neuropsychiatric Inventory (NPI) and Caregiver Distress (NPI-D) - Secondary Outcomes

  10 weeks

• Change from Baseline to the End of the Fixed Dose Period in Parkinson's Disease Questionnaire-39 (PDQ-39) - Secondary Outcomes

  10 weeks

Other Outcomes (3)

• 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).

  10 weeks

• To compare the effect of ENT-01 on non-motor symptoms of Parkinson's disease for skin-temperature determined Circadian rhythm and weight.

  10 weeks

• To compare the effect of ENT-01 on non-motor symptoms of Parkinson's disease for weight.

  10 weeks

Study Arms (1)

Active Treatment

EXPERIMENTAL

ENT-01 tablet will be taken once daily by mouth.

Drug: Active Investigational Treatment ENT-01

Interventions

Active Investigational Treatment ENT-01 DRUG

ENT-01 will be administered in tablet form, once daily. Other Names: ENT-01

Active Treatment

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Enterin Inc.: lead

Study Sites (3)

Neuro Pain Medical Center

Fresno, California, 93710, United States

Location

Evolution Research Group - Neuroscience Research Institution

Toms River, New Jersey, 08755, United States

Location

Elias Research - Neurology Diagnostics Research

Dayton, Ohio, 45459, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Dementia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Michael Zasloff, MD, Ph.D

  Enterin Inc.

  STUDY CHAIR

• Denise Barbut, MD, FRCP

  Enterin Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: May 6, 2019
• Study Start: March 1, 2024
• Primary Completion: June 15, 2025
• Study Completion: December 15, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

US (3)