Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

This is a phase 2b, double-blind, placebo controlled proof-of-concept study of a an oral small molecule selective inhibitor of p38 alpha kinase, neflamapimod, administered for 24 weeks in subjects with mild Alzheimer's disease. The primary objective is to demonstrate significant improvement relative to placebo-treatment in episodic memory function, as assessed by the Hopkins Verbal Learning Test. Secondary endpoints include Clinical Dementia Rating scale (CDR), Wechsler Memory Scale (WMS), Mini-Mental-Status-Examination (MMSE) and Cerebrospinal fluid (CSF) biomarkers of AD disease activity and progression.

Key facts

Study ID

NCT03402659

Run by

EIP Pharma Inc

People needed

161

Starts

2017-12-29

Expected to finish

2019-07-31

Last updated by the study team

2021-10-27

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women age 55 to 85 years, inclusive.
• Willing and able to provide informed consent.
• Must have mild cognitive impairment (MCI) or mild AD with evidence of progression ("Mild-AD"), as defined by the following:
• CDR-Global Score of 0.5 or 1.0, with CDR memory subscore of at least 0.5.
• MMSE score ranging from 20 to 28, inclusive.
• Positive biomarker for AD, as defined by a CSF Aβ1-42R below the threshold and phospho-tau above the threshold for the assay utilized in the study and assessed by the central laboratory.
• Computed tomography (CT) or magnetic resonance imaging (MRI) findings within 2 years of Screening that are compatible with AD and no other pathologic processes that might potentially account for the subject's cognitive impairment.
• If the subject is taking a single drug for AD (e.g., donepezil or other cholinesterase inhibitors or memantine; dual therapy is excluded), he/she has been on a stable dose for at least 2 months prior to baseline, and the dose must remain unchanged during the study unless required for management of adverse events (AEs).
• Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
• Must have reliable informant or caregiver.

You may not qualify if…

• Evidence that the primary basis for cognitive impairment is neurodegenerative disease other than AD, including, but not limited to, vascular dementia, dementia with Lewy bodies, and Parkinson's disease.
• 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 Columbia-Suicide Severity Rating Scale (C-SSRS), or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide.
• History of major and active psychiatric disorder, moderate to severe depressive symptoms, and or other concurrent medical condition that, EIP-VX17-745-304, Version 1.0, 17 November, 2017 Page 7 of 46 EIP Pharma, LLC Confidential 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.
• History of cancer within the last 5 years, except basal cell carcinoma, squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years.
• Poorly controlled clinically significant medical illness.
• History of serum B12 abnormality, anemia with hemoglobin ≤10 g/dL, thyroid function abnormality, electrolyte abnormality, or positive syphilis serology that have not been corrected and/or otherwise addressed.
• History of epilepsy or unexplained seizure within the past 5 years.
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 × the upper limit of normal (ULN), total bilirubin >2 × ULN, and/or International Normalized Ratio (INR) >1.5
• Known human immunodeficiency virus, hepatitis B, or active hepatitis C virus infection.
• Subject participated in a study of an investigational drug less than 3 months or 5 half-lives of the investigation drug, whichever is longer, before enrollment in this study.

Where it is running

• Alliance for Research — Long Beach, California, United States
• Pacific Research Network — San Diego, California, United States
• CITrials — Santa Ana, California, United States
• Southern California Research, LLC — Simi Valley, California, United States
• Viking Clinical Research — Temecula, California, United States
• Miami Dade Medical Research Institute — Miami, Florida, United States
• Sensible Healthcare, LLC — Ocoee, Florida, United States
• Anchor Neuroscience — Pensacola, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Suncoast Neuroscience Associates, Inc. — St. Petersburg, Florida, United States
• Florida Premier Research Institute — Winter Park, Florida, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• MassGeneral Institute for Neurodegenerative Disease — Charlestown, Massachusetts, United States
• Manhattan Behavioral Medicine — New York, New York, United States
• Alzheimer's Memory Center and Research Institute — Charlotte, North Carolina, United States
• Northwest Clinical Research Center — Seattle, Washington, United States
• Neuro HK, s.r.o. POLIKLINIKA CHOCEŇ, a.s. — Choceň, Czechia
• Cerebrovaskulární poradna s.r.o. — Moravská Ostrava, Czechia
• Clintrial S.R.O — Prague, Czechia
• Private Psychiatric Centre — Prague, Czechia
• Vestra Clinics S.R.O — Rychnov nad Kněžnou, Czechia
• CCBR Clinical Research, Aalborg — Aalborg, Denmark
• CCBR Clinical Research, Ballerup — Ballerup Municipality, Denmark
• CCBR Clinical Research, Vejle — Vejle, Denmark
• Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, Netherlands

Full record on ClinicalTrials.gov

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