Cognitive Effects of Oral p38 Alpha Kinase Inhibitor Neflamapimod in Dementia With Lewy Bodies

Inclusion Criteria:

1. Men and women aged ≥55 years.
2. Subject or subject's legally authorized representative is willing and able to providewritten informed consent.
3. Probable DLB and identified cognitive deficits, according to current consensuscriteria (McKeith et al, 2017), specifically one core clinical feature and a positiveDaTscan. If a negative DaTscan, but the subject has historical PSG-verified RBD, thesubject would also qualify.
4. MMSE score of 15-28, inclusive, during Screening.
5. Currently receiving cholinesterase inhibitor therapy, having received such therapy forgreater than 3 months and on a stable dose for at least 6 weeks at the time ofrandomization. Except for reducing the dose for tolerability reasons, the dose ofcholinesterase inhibitor may not be modified during the study.
6. Normal or corrected eye sight and auditory abilities, sufficient to perform allaspects of the cognitive and functional assessments.
7. No history of learning difficulties that may interfere with their ability to completethe cognitive tests.
8. Must have reliable informant or caregiver.

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'sdisease (AD), or Parkinson's disease (PD).
2. Suicidality, defined as active suicidal thoughts within 6 months before Screening orat Baseline, defined as answering yes to items 4 or 5 on the C-SSRS, or history ofsuicide attempt in previous 2 years, or, in the Investigator's opinion, at seriousrisk of suicide.
3. Ongoing major and active psychiatric disorder and/or other concurrent medicalcondition that, in the opinion of the Investigator, might compromise safety and/orcompliance 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 (bloodpressure >180 mmHg systolic or 100 mmHg diastolic); myocardial infarction within 6months; uncompensated congestive heart failure or other significant cardiovascular,pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrinedisorders or other disease that would interfere with assessment of drug safety.
6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 × the upperlimit of normal (ULN), total bilirubin >1.5 × ULN, and/or International NormalizedRatio (INR) >1.5.
7. Known human immunodeficiency virus, hepatitis B, or active hepatitis C virusinfection.
8. Participated in a study of an investigational drug less than 3 months or 5 half-livesof 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 toadhere to contraception requirements specified in the protocol.
11. If female who has not has not reached menopause >1 year previously or has not had ahysterectomy or bilateral oophorectomy/salpingo-oophorectomy, has a positive pregnancytest result during Screening and/or is unwilling or unable to adhere to thecontraception requirements specified in the protocol.