A Double-Blind, Placebo-Controlled 16-Week Study of the Cognitive Effects of the Oral P38 Alpha Kinase Inhibitor Neflamapimod in Dementia with Lewy Bodies (DLB)

Phase 2

Completed

Conditions: Dementia with Lewy Bodies (DLB)
dementia
neurodegenerative disease
10012272

Registration Number: NL-OMON49197

Lead Sponsor: EIP Pharma Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 13

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.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints:<br /><br>*Change in the composite score of the NTB, including assessments of attention,<br /><br>executive function, and visuospatial function in neflamapimod treated-subjects<br /><br>as compared to the placebo-treated subjects. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>Change in CDR-SB in neflamapimod-treated subjects compared to<br /><br>placebo-recipients.<br /><br>Change in MMSE in neflamapimod-treated subjects compared to<br /><br>placebo-recipients.<br /><br>Change in NPI-10 domains in neflamapimod-treated subjects compared to<br /><br>placebo-recipients.<br /><br>Change in International Shopping List Test immediate & delayed recall and<br /><br>recognition in neflamapimod-treated subjects compared to placebo-recipients.<br /><br>Change in Timed Up and Go Test.<br /><br>Change in EEG parameters.</p><br>