RewinD-LB - Clinical Study of Neflamapimod in Patients With Dementia With Lewy Bodies (NCT05869669) | Clinical Trial Compass
CompletedPhase 2
RewinD-LB - Clinical Study of Neflamapimod in Patients With Dementia With Lewy Bodies
United States159 participantsStarted 2023-05-01
Plain-language summary
The purpose of this study is to determine whether neflamapimod can improve learning skills, problem solving skills, and memory loss in people diagnosed with DLB. More specifically, improvement in verbal learning, memory, and attention, as well as cognitive and functional performance will be measured.
Who can participate
Age range55 Years
SexALL
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Inclusion criteria
✓. Men and women aged ≥55 years.
✓. Subject or subject's legally authorized representative is willing and able to provide written informed consent.
✓. 3\. Probable DLB by consensus criteria (McKeith et al, 2017), including a positive DaTscan™. Specifically, the subject must have the presence of dementia in association with:
✓. CDR Global Score 0.5 (very mild dementia) or 1.0 (mild dementia) during Screening
✓. Background dementia therapy:
✓. Normal or corrected eyesight and auditory abilities, sufficient to perform all aspects of the cognitive and functional assessments.
✓. No history of learning difficulties that may interfere with their ability to complete the cognitive tests.
✓. Received vaccination for SARS-CoV-19 unless medical contraindications prevent being vaccinated, or has a history of natural infection.
Exclusion criteria
✕. 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).
✕. Plasma ptau181 result above the threshold that indicates evidence of pathology associated with Alzheimer's disease at Screening.
✕. 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.
What they're measuring
1
Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)
Timeframe: 16 weeks
2
Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants, Drug Batch A Compared to Drug Batch B (Open-label Extension)
✕. 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.
✕. Diagnosis of alcohol or drug abuse within the previous 2 years.
✕. 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.
✕. 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. If patient is taking blood thinners (e.g., warfarin), and has no known liver issues, INR \>3.
✕. Known human immunodeficiency virus, hepatitis B, or active hepatitis C virus infection.