CompletedPhase 2Results posted

A PET Study of the Effects of p38 MAP Kinase Inhibitor, VX-745, on Amyloid Plaque Load in Alzheimer's Disease (AD)

A Clinical Study of Two Doses of a Selective p38 MAP Kinase Inhibitor, VX-745, to Evaluate the Effects of 12-Week Oral Twice-Daily Dosing on Amyloid Plaque Load as Assessed by Quantitative Dynamic 11C-PiB Positive Emission Tomography (PET) Amyloid Scanning

Lead sponsor

EIP Pharma Inc

Asset

Neflamapimod

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET)•MMSE 20-28

Primary endpoints

•Amyloid Plaque Burden by 11C-PiB PET•Number of 11C-PiB Responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDEIP-VX00-745-302

NCT IDNCT02423122

Timeline

Milestones

Study start2015-04 (month precision)

Study first posted2015-04-22estimated

Primary completion2016-07actual (month precision)

Study completion2016-09actual (month precision)

Last update posted2019-06-14actual

Results first posted2019-06-14actual

Assets

Drug assets

Neflamapimod

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Willing and able to provide informed consent

•Diagnosis of mild cognitive impairment (MCI) due to probable AD or of mild AD

•MMSE range: 20 to 28

•Evidence of amyloid pathology by amyloid PET scan

•Participants may be taking medications for AD, provided that the dose of these medications has been stable for >3 months

•Proficiency in Dutch and adequate visual and auditory abilities to be able to perform all aspects of the cognitive and functional tests

•Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments

Exclusion criteria

•Evidence of neurodegenerative disease other than AD

•Inability for any reason to undergo PET and fMRI scans (including notably: history of allergic reaction of any severity to 11C-PiB injection; pacemaker, vascular stent or stent graft)

•Psychiatric disorder that would compromise ability to comply with study requirements

•Significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder or metabolic/endocrine disorders or other disease that would preclude treatment with p38 MAP kinase inhibitor and/or assessment of drug safety and efficacy

•Recent (<90 days) changes to AD medications prescribed for cognitive reasons or with the potential to impact cognition

•Participation in a study of an investigational drug less than 6 months or 5 half-lives of the investigational drug, whichever is longer, before enrollment in the study

•Male subjects with female partner of child-bearing potential who are unwilling or unable to adhere to contraception requirements

•Female subjects who have not reached menopause or have not had a hysterectomy or bilateral oophorectomy/salpingoophorectomy

•Positive urine or serum pregnancy test or plans desires to become pregnant during the course of the trial

•Any factor deemed by the investigator to be likely to interfere with study conduction

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Memory

Amyloid biomarkers

Other (unclassified)

Memory

4 endpoints

Secondary/protocol endpoint

Wechsler Memory Scale (WMS) Immediate Recall Composite

Time frame:Baseline to Day 84

descriptive

Secondary/protocol endpoint

Wechsler Memory Scale (WMS) Delayed Recall Composite

Time frame:Change from baseline to Day 84

descriptive

Secondary/registry result

Wechsler Memory Scale (WMS) Immediate Recall Composite

Time frame:Baseline to Day 84

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Neflamapimod (VX-745) Dose 1n=8 Participants	7.0	11.0
Neflamapimod (VX-745) Dose 2n=7 Participants	13.4	12.2

Secondary/registry result

Wechsler Memory Scale (WMS) Delayed Recall Composite

Time frame:Change from baseline to Day 84

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Neflamapimod (VX-745) Dose 1n=8 Participants	7.5	7.0
Neflamapimod (VX-745) Dose 2n=7 Participants	10.4	11.9

Amyloid biomarkers

2 endpoints

Primary/protocol endpoint

Percent Change From Baseline in Amyloid Plaque Burden by 11C-PiB PET

Time frame:Baseline compared to following 12 weeks' dosing with VX-745

percent change from baseline, improvement

Primary/registry result

Percent Change From Baseline in Amyloid Plaque Burden by 11C-PiB PET

Time frame:Baseline compared to following 12 weeks' dosing with VX-745

percent change from baseline, improvement

Posted result

Group	Value (median), percentage change from baseline	Reported bounds
Neflamapimod (VX-745) Dose 1n=8 Participants	-4.57	--11.65 - 4.83
Neflamapimod (VX-745) Dose 2n=7 Participants	4.57	-0.56 - 12.25

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Number of 11C-PiB Responders

Time frame:Day 84

change from baseline, improvement

Primary/registry result/low confidence

Number of 11C-PiB Responders

Time frame:Day 84

change from baseline, improvement

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Neflamapimod (VX-745) Dose 1n=8 Participants	3	-
Neflamapimod (VX-745) Dose 2n=7 Participants	1	-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Tormahlen NM, Martorelli M, Kuhn A, Maier F, Guezguez J, Burnet M, Albrecht W, Laufer SA, Koch P. Design and Synthesis of Highly Selective Brain Penetrant p38alpha Mitogen-Activated Protein Kinase Inhibitors. J Med Chem. 2022 Jan 27;65(2):1225-1242. doi: 10.1021/acs.jmedchem.0c01773. Epub 2021 May 11.
PMID33974419via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.