Status:
COMPLETED
Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease
Lead Sponsor:
EIP Pharma Inc
Collaborating Sponsors:
Worldwide Clinical Trials
Amsterdam UMC, location VUmc
Conditions:
Alzheimer Disease
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
Brief Summary
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 wit...
Detailed Description
Details provided elsewhere.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT03402659
Start Date
December 29 2017
End Date
July 31 2019
Last Update
October 27 2021
Active Locations (38)
Enter a location and click search to find clinical trials sorted by distance.
1
Alliance for Research
Long Beach, California, United States, 90807
2
Pacific Research Network
San Diego, California, United States, 92103
3
CITrials
Santa Ana, California, United States, 92705
4
Southern California Research, LLC
Simi Valley, California, United States, 93065