VIP

CompletedPhase 2

Effect of Neflamapimod on Brain Inflammation in Alzheimer's Disease Patients

Effect of Neflamapimod (VX-745) on Brain Inflammation Using Positron Emission Tomography (PET) Scan in Alzheimer's Disease (AD) Patients

Lead sponsor

University Hospital, Toulouse

Asset

Neflamapimod

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•MMSE ≥20

Primary endpoint

•Brain inflammation

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

NCT IDNCT03435861

Org study IDRC31/16/8371

Timeline

Milestones

Study first posted2018-02-19actual

Study start2018-10-08actual

Primary completion2021-04-30actual

Study completion2021-06-30actual

Last update posted2023-06-22actual

Assets

Drug assets

Neflamapimod

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•A group of 40 AD patients at an early stage (prodromal) will be recruited. Patient's recruitment will follow the most recent research criteria for AD in its "typical form" (Dubois, Feldman et al. 2014):

-Age 50 - 90 (inclusive)

-Willing and able to provide informed consent

-Objective memory impairment corroborated by level of performance on a standardized memory test (Free and Cued Selective Reminding test, (Grober, Hall et al. 2008)) < -1.5 DS according to established norms and

-Documented cerebral amyloidopathy using CSF analysis or PET amyloid imaging and

-Early stage of the disease (Mini Mental State Examination > 20) (Folstein, Robins et al. 1983)

Exclusion criteria

•• Evidence of neurodegenerative disease other than AD

-Inability for any reason to undergo MRI scans (e.g. pacemaker). Patients who require sedation for screening procedures such as MRI may receive a short-acting sedative.

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

-History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years

-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 (<60 days) changes to AD medications prescribed for cognitive reasons or with the potential to impact cognition

-Psychotropic drugs taken within 1 month. Anticoagulant drugs taken within 1 week.

-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

-History of alcohol and/or illicit drug abuse within 6 months.

-Infection with hepatitis A, B or C or HIV.

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

Endpoints (38)

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

Fluid / digital biomarkers

Executive function / language

Other (unclassified)

Memory

Tau biomarkers

Memory

2 endpoints

Secondary/protocol endpoint

Neuropsychological assessment to assess the following cognitive functions 1:

Time frame:3 month

descriptive

Secondary/protocol endpoint

Neuropsychological assessment to assess the following cognitive functions 2:

Time frame:3 month

descriptive

Executive function / language

5 endpoints

Secondary/protocol endpoint

Neuropsychological assessment to assess the following cognitive functions 1.1:

Time frame:3 month

descriptive

Secondary/protocol endpoint

Neuropsychological assessment to assess the following cognitive functions 2.2:

Time frame:3 month

descriptive

Secondary/protocol endpoint

Neuropsychological assessment to assess the following cognitive functions 3:

Time frame:3 month

descriptive

Secondary/protocol endpoint

Neuropsychological assessment to assess the following cognitive functions 4:

Time frame:3 month

descriptive

Secondary/protocol endpoint

Neuropsychological assessment to assess the following cognitive functions 5:

Time frame:3 month

descriptive

Tau biomarkers

1 endpoint

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 17

Time frame:3 month

descriptive

Fluid / digital biomarkers

27 endpoints

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation1

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 2

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 3

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 4

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 5

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 6

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 7

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 8

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 9

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 10

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 11

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 12

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 13

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 14

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 15

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 16

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 18

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 19

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 20

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 21

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 22

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 23

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 24

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 25

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 26

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 27

Time frame:3 month

descriptive

Secondary/protocol endpoint

Blood and CSF biomarkers of inflammation 28

Time frame:3 month

descriptive

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

brain inflammation assessed by [18F]-DPA714, Standard Uptake Value (SUV)

Time frame:3 month

descriptive

Primary/protocol endpoint/low confidence

brain inflammation assessed by [18F]-DPA714, Standard Uptake Value (SUV) 2

Time frame:3 month

descriptive

Primary/protocol endpoint/low confidence

brain inflammation assessed by [18F]-DPA714, Standard Uptake Value (SUV)3

Time frame:3 month

descriptive

Publications (2)

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.