Dementia with Lewy Bodies (DLB) MedDRA version: 20.0 Level: PT Classification code 10067889 Term: Dementia with Lewy bodies System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Neflamapimod
Product Code: VX-745
Pharmaceutical Form: Capsule
INN or Proposed INN: Neflamapimod
CAS Number: 209410-46-8
Current Sponsor code: VX-745
Other descriptive name: Neflamapimod
Sponsors
EIP Pharma Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Men and women aged =55 years. 2.Subject or subject’s legally authorized representative is willing and able to provide written informed consent. 3.Probable DLB and identified cognitive deficits, according to current consensus criteria (McKeith et al, 2017), specifically one core clinical feature and a positive DaTscan. If a negative DaTscan, but the subject has historical PSG-verified RBD, the subject would also qualify. 4.MMSE score of 15-28, inclusive, during Screening. 5.Currently receiving cholinesterase inhibitor therapy, having received such therapy for greater than 3 months and on a stable dose for at least 6 weeks at the time of randomization. Except for reducing the dose for tolerability reasons, the dose of cholinesterase inhibitor may not be modified during the study. 6.Normal or corrected eye sight and auditory abilities, sufficient to perform all aspects of the cognitive and functional assessments. 7.No history of learning difficulties that may interfere with their ability to complete the cognitive tests. 8.Must have reliable informant or caregiver. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 51
Exclusion criteria
Exclusion criteria: 1.Diagnosis of any other ongoing central nervous system (CNS) condition other than DLB, including, but not limited to, post-stroke dementia, vascular dementia, Alzheimer’s disease (AD), or Parkinson’s disease (PD). 2.Suicidality, defined as active suicidal thoughts within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the C-SSRS, or history of suicide attempt in previous 2 years, or, in the Investigator’s opinion, at serious risk of suicide. 3.Ongoing major and active psychiatric disorder and/or other concurrent medical condition that, in the opinion of the Investigator, might compromise safety and/or compliance with study requirements. 4.Diagnosis of alcohol or drug abuse within the previous 2 years. 5.Poorly controlled clinically significant medical illness, such as hypertension (blood pressure >180 mmHg systolic or 100 mmHg diastolic); myocardial infarction within 6 months; uncompensated congestive heart failure or other significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would interfere with assessment of drug safety. 6.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 × the upper limit of normal (ULN), total bilirubin >1.5 × ULN, and/or International Normalized Ratio (INR) >1.5. 7.Known human immunodeficiency virus, hepatitis B, or active hepatitis C virus infection. 8.Participated in a study of an investigational drug less than 3 months or 5 half-lives of an investigational drug, whichever is longer, before enrollment in this study. 9.History of previous neurosurgery to the brain. 10.If male with female partner(s) of child-bearing potential, unwilling or unable to adhere to contraception requirements specified in the protocol. 11.If female who has not has not reached menopause >1 year previously or has not had a hysterectomy or bilateral oophorectomy/salpingo-oophorectomy, has a positive pregnancy test result during Screening and/or is unwilling or unable to adhere to the contraception requirements specified in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Change in the composite score of the NTB, including assessments of attention, executive function, and visuospatial function in neflamapimod treated-subjects as compared to the placebo-treated subjects;Timepoint(s) of evaluation of this end point: Timepoints at which NTB will be performed: Screening, Baseline (Day 1), W4 (Day 28), W8 (Day 56), W16 (Day 112) and End of Trial visit.;Main Objective: The primary objective is to evaluate the effect of neflamapimod on cognitive function as assessed in a study-specific Neuropsychological Test Battery (NTB) comprised of: •Cogstate Detection test (DET) •Cogstate Identification test (IDN) •Cogstate One Card Learning test (OCL) •Cogstate One Back test (ONB) •Letter Fluency Test •Category Fluency Test (CFT) ;Secondary Objective: The secondary objectives are to: •Evaluate the effects of neflamapimod on informant/caretaker evaluation of cognition and function, as assessed by the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) •Assess the effects of neflamapimod on general cognition, as assessed by the Mini Mental State Examination (MMSE) •Assess the effects of neflamapimod on episodic memory, as assessed by the International Shopping List Test (ISLT). •Assess the effects of neflamapimod on select domains of the 10-item Neuropsychiatric Inventory (NPI-10), including depression (dysphoria), anxiety, hallucinations, and agitation/aggression. •Evaluate the effects of neflamapimod on motor function as assessed by the Timed Up and Go Test (TUG). •Evaluate the effects of neflamapimod on quantitative electroencephalography (EEG) parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Change in CDR-SB in neflamapimod-treated subjects compared to placebo-recipients. •Change in MMSE in neflamapimod-treated subjects compared to placebo-recipients. •Change in NPI-10 domains in neflamapimod-treated subjects compared to placebo-recipients. •Change in ISLT in neflamapimod-treated subjects compared to placebo-recipients. •Change in Timed Up and Go Test. •Change in EEG parameters.;Timepoint(s) of evaluation of this end point: CDR-SB: Baseline visit (Day 1), W8 (Day 56), W16 (Day 112) and End of Trial visit. MMSE: Screening, Baseline visit (Day 1), W8 (Day 56), W16 (Day 112) and End of Trial visit. NPI-10: Screening, Baseline visit (Day 1), W4 (Day 28), W8 (Day 56), W16 (Day 112) and End of Trial visit. ISLT: Screening, Baseline (Day 1), W4 (Day 28), W8 (Day 56), W16 (Day 112) and End of Trial visit. Timed Up and Go Test: Baseline (Day 1), W8 (Day 56), W15 (Day 112) and ET visit. EEG: Baseline visit (Day 1), W16 (Day 112), ET visit. | — |
Countries
Netherlands, United States
Contacts
Public ContactProject Management
Worldwide Clinical Trials Limited
Outcome results
None listed