A Study of E2027 in Participants With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) With or Without Amyloid Copathology

Completed · Phase 2

Conditions studied: Lewy Body Disease, Parkinson Disease

In brief

The purpose of study is to demonstrate the pharmacodynamic (PD) effects of E2027 on cerebrospinal fluid (CSF) cyclic guanosine monophosphate (cGMP) in participants with DLB and PDD with and without amyloid copathology after 9 weeks of treatment.

Key facts

Study ID

NCT04764669

Run by

Eisai Inc.

People needed

34

Starts

2021-02-25

Expected to finish

2022-01-27

Last updated by the study team

2022-09-26

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age 50 to 85 years, inclusive at time of consent
• Meet criteria for probable DLB (as defined by the 4th report of the DLB Consortium) or meet criteria for probable PDD (as defined by the task force of the Movement Disorder Society).
• Mini-mental state examination (MMSE) greater than (>) 14 and less than (<) 26 at Screening Visit
• For DLB participants, have experienced visual hallucinations since onset of their DLB
• If receiving acetylcholinesterase inhibitors (AChEIs), must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment naive participants can be entered into the study but there should be no plans to initiate treatment with AChEIs from Screening to the end of the study.
• If receiving memantine, must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment naive participants can be entered into the study but there should be no plans to initiate treatment with memantine from Screening to the end of the study.
• If receiving Parkinson's disease medications, must have been on a stable dose for at least 4 weeks before Screening Visit, with no plans for dose adjustment during the study.
• Must have an identified caregiver or informant who is willing and able to provide follow up information on the participant throughout the course of the study.
• Provide written informed consent.

You may not qualify if…

• Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the participant's DLB or PDD, including any comorbidities detected by clinical assessment or magnetic resonance imaging (MRI) (identification of amyloid copathology is not exclusionary)
• History of transient ischemic attacks or stroke within 12 months of Screening
• Modified Hachinski Ischemic Scale >4
• Parkinsonian (extrapyramidal) features with Hoehn and Yahr Scale (HYS) stage 4 or higher
• Any major psychiatric diagnosis, including schizophrenia, bipolar disorder and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition
• Geriatric Depression Scale (GDS) score >8
• Severe visual or hearing impairment that may interfere with the participant study assessments including cognitive testing
• Any contraindications to lumbar puncture
• History of deep brain stimulation or other neurosurgical procedure for Parkinson's disease
• Has thyroid stimulating hormone (TSH) above normal range
• Abnormally low serum vitamin B12 levels (< the lower limit of normal [LLN]) for the testing laboratory
• Contraindications to MRI scanning
• Evidence of other clinically significant lesions that suggest a dementia diagnosis other than DLB or PDD on brain MRI at Screening
• Other significant pathological findings on brain MRI at Screening
• Hypersensitivity to E2027 or any of the excipients
• A prolonged corrected QT interval calculated using Fridericia's formula (QTcF) as demonstrated by triplicate ECG at the Screening or Baseline Visit (that is, mean value >450 millisecond [msec])
• Had symptomatic orthostatic hypotension or symptomatic orthostatic tachycardia which resulted in hospitalization or urgent medical review in hospital in the past 12 months before Screening
• Any other clinically significant abnormalities in vital signs, ECG and laboratory values that in the opinion of the investigator, require further investigation or treatment or that may interfere with study procedures or safety
• Malignant neoplasms within 3 years of Screening (except for basal or squamous cell carcinoma of the skin, or localized prostate cancer in male participants). Participants who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before Screening need not be excluded.
• Has a "yes" answer to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening
• Known or suspected history of drug or alcohol dependency or abuse within 2 years before Screening, current use of recreational drugs or a positive urine drug test at Screening.
• Any other medical conditions (example, cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator may affect the participant's safety or interfere with the study assessments
• Taking any of the prohibited medications or not meeting the requirements regarding stable doses of permitted medications
• Participation in a clinical study involving any investigational drug/device for DLB or PDD within 6 months before Screening or any other investigational drug/device in the 8 weeks or 5 half-lives (whichever is longer) of the study medication before Screening unless it can be documented that the participant was in a placebo treatment arm
• Planned surgery which requires general, spinal or epidural anesthesia that will take place during the study.

Where it is running

• Banner Sun Health Research Institute — Sun City, Arizona, United States
• JEM Research Institute — Atlantis, Florida, United States
• Elias Research Associates (Allied Biomedical Research Institute) — Miami, Florida, United States
• Napa Research — Pompano Beach, Florida, United States
• University of South Florida, Department of Psychiatry and Behavioral Neurosciences — Tampa, Florida, United States
• Alzheimer's Research and Treatment Center — Wellington, Florida, United States
• University of Kentucky, Dept of Neurology, Sanders Brown Center on Aging — Lexington, Kentucky, United States
• Advanced Memory Research Institute of NJPC — Toms River, New Jersey, United States
• Neurological Associates of Albany, PC — Albany, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Neurology Diagnostics, Inc. — Dayton, Ohio, United States
• Cleveland Clinic, Lou Ruvo Center for Brain Health at Lakewood Hospital — Lakewood, Ohio, United States
• Summit Research Network (Oregon) Inc. — Portland, Oregon, United States
• Toronto Memory Program — Toronto, Canada

Full record on ClinicalTrials.gov

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