WithdrawnPhase 1

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

A Multicenter, Open Label Study to Evaluate Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Dementia.

Lead sponsor

Enterin Inc.

Asset

ENT-01

Listed sites

Recruiting sites

Enrollment

actual

Study population

Lewy body dementia

Key I/E criteria

•MoCA ≤24•Study partner/caregiver required

Primary endpoint

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

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

Org study IDENT-01-1b-19-01

NCT IDNCT03938922

Timeline

Milestones

Study first posted2019-05-06actual

Study start2024-03-01estimated

Last update posted2024-03-01actual

Primary completion2025-06-15estimated

Study completion2025-12-15estimated

Assets

Drug assets

ENT-01

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age30 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (8)

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

Other (unclassified)

Global cognition

Memory

Behavior / neuropsychiatric

Caregiver / quality of life

Global cognition

1 endpoint

Secondary/protocol endpoint

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

Time frame:10 weeks

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Memory

1 endpoint

Primary/protocol endpoint

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

Time frame:10 weeks

ratio, descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

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

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

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

change from baseline, improvement

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

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

change from baseline, improvement

Other/protocol endpoint/low confidence

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

change from baseline, improvement

Other/protocol endpoint/low confidence

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

descriptive

Other/protocol endpoint/low confidence

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

Time frame:10 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.