Phase 1b Study in Parkinson’s Disease Dementia
A Multicenter, Randomized, Double Blind Study to Evaluate Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson’s Disease Dementia. The study has been published on ClinicalTrials.gov under the title ‘A Study to Evaluate ENT-01 for the Treatment of Parkinson’s Disease Dementia’ and ClinicalTrials.gov Identifier NCT03938922. The study will begin in June 2019 and will be conducted at up to 40 sites across the country. Approximately forty (40) patients with Parkinson’s Disease Dementia will be included in the study, which will require 5 visits over a period of 2 months. For further information, please go to ClinicalTrials.gov.
Enterin is looking for patients with Parkinson’s Disease Dementia. If you are interested in learning more about participating in our Phase 1b study, please reach out to the most convenient clinical study site to determine if you qualify.
In order to qualify for this study, patients must meet certain requirements, known as inclusion criteria. Some key inclusion criteria include the following:
- The participant must be 30-90 years old;
- The participant must have been diagnosed with Parkinson’s Disease, defined as the presence of at least two of the following features: rest tremor, rigidity, bradykinesia and/or akinesia, postural and gait abnormalities;
- The participant must have dementia as defined by a decline in cognitive function, which in the opinion of the investigator has resulted in functional impairment; and
- The participant and/or a legally authorized representative / caregiver must provide written informed consent and be willing and able to comply with study procedures.