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Parkinson DiseasePhase 1NCT03938922

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

A Phase 1 study testing Active Investigational Treatment ENT-01 in people with Parkinson Disease and Dementia, run by Enterin Inc. at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 90 years
Conditions the study is for
Parkinson Disease, Dementia
What is being tested?
Active Investigational Treatment ENT-01
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
1 Mar 2024to 15 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 30 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Elias Research - Neurology Diagnostics Research

    Dayton, Ohio, 45459

  • Neuro Pain Medical Center

    Fresno, California, 93710

  • Evolution Research Group - Neuroscience Research Institution

    Toms River, New Jersey, 08755

Other trials in United States

About this study

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.

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.

Read the detailed 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.

Being tested
Active Investigational Treatment ENT-01
Keywords
PDD, parkinson's disease-related dementia
Medical subject headings
Parkinson Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Investigational Treatment ENT-01Drug

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

    Other Names:

    ENT-01

Study groups in NCT03938922
Study groupRoleWhat they receive
Active TreatmentExperimentalENT-01 tablet will be taken once daily by mouth.
Receives: Drug: Active Investigational Treatment ENT-01

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 10 weeks

Secondary outcomes (4)

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

    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.

    Measured: 10 weeks

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

    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.

    Measured: 10 weeks

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

    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.

    Measured: 10 weeks

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

    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.

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2019
  2. Study start1 Mar 2024 (estimated)
  3. Primary completion15 Jun 2025 (estimated)
  4. Study completion15 Dec 2025 (estimated)

Why it stopped: Compound will not be studied for indication

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03938922
Sponsor's protocol ID
ENT-01-1b-19-01
Status last verified
Feb 2024
First submitted
18 Apr 2019
Last updated
1 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Active Investigational Treatment ENT-01 in people with Parkinson Disease and Dementia, run by Enterin Inc. at 3 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 12 inclusion and 14 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: withdrawn, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Cognition Improvement by Dementia Severity Rating Scale (DSRS) - Primary Outcome (time frame: 10 weeks). 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 NCT03938922.

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 1 Mar 2024.

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