Status:
Active, No Longer Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Enterin Inc
Enrollment:
40
Study Design:
This is a phase 1, multicenter (3 sites in the USA), open-label study assessing the safety and tolerability of ENT-01 in participants with PDD. The study will recruit participants aged 30-90 years with a clinical diagnosis of PD with dementia. Only MoCA score of < 24 will be included. Standard exclusionary criteria are applied. All participants will receive the study drug as daily oral dosing for 10 weeks. The study will require 5 visits. Participants will be allowed to adjust the medication dose as specified in the protocol.
Rationale:
The primary outcome measure is cognition improvement using the Dementia Severity Rating Scale (DSRS), assessed at baseline and after 10 weeks of treatment. The secondary outcomes, also assessed at baseline and after 10 weeks of treatment are: 1. Change in the MoCA; 2. Change in symptoms adapted for Parkinson’s disease (SAPS-PD). This measures the frequency and/or severity of hallucinations and delusions; 3. Change in Neuropsychiatric Inventory (NPI) and Caregiver Distress (NPI-D); and 4. Change in Parkinson’s Disease Questionnaire-39 (PDQ-39). The study will also assess other outcome measures: 1. Change in MDS-UPDRS; 2. Change in skin temperature-determined circadian rhythm; and 3. Change in body weight.
Comments:
This study intends to explore the ability of ENT-01 to influence α-synuclein aggregation and the subsequent impact on cognitive symptoms. The timeframe to assess this effect is 10 weeks. Open label design of the study will preclude any meaningful conclusions regarding potential efficacy. Together with the RASMET (NCT03047629) and KARMET (NCT02781791 and NCT04483479) studies, Enterin are building a solid base of patient experience with ENT-01.
