Alzheimer DiseasePhase 2REVERSE-SDNCT03402659
Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease
A Phase 2 study testing neflamapimod in people with Alzheimer Disease, run by EIP Pharma Inc at 38 sites in 5 countries.
Trial 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 with mild Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- neflamapimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 38 sitesin 5 countries
- Study dates
- 29 Dec 2017to 31 Jul 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
38 sites in 5 countries.
38 sites in 5 countries
United States16 sites
Northwest Clinical Trials
Boise, Idaho, 83704
MassGeneral Institute for Neurodegenerative Disease
Charlestown, Massachusetts, 02129
Alzheimer's Memory Center and Research Institute
Charlotte, North Carolina, 28270
Alliance for Research
Long Beach, California, 90807
Miami Dade Medical Research Institute
Miami, Florida, 33176
Manhattan Behavioral Medicine
New York, New York, 10036
Sensible Healthcare, LLC
Ocoee, Florida, 34761
Anchor Neuroscience
Pensacola, Florida, 32502
Progressive Medical Research
Port Orange, Florida, 32127
Pacific Research Network
San Diego, California, 92103
CITrials
Santa Ana, California, 92705
Northwest Clinical Research Center
Seattle, Washington, 98007
Southern California Research, LLC
Simi Valley, California, 93065
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33713
Viking Clinical Research
Temecula, California, 92591
Florida Premier Research Institute
Winter Park, Florida, 32789
United Kingdom11 sites
MAC Clinical Research Tankersley
Barnsley, S75 3DL
Re:Cognition Health Birmingham
Birmingham, B16 8LT
MAC Clinical Research Blackpool
Blackpool, FY2 0JH
Fulbourn Hospital
Cambridge, CB21 5EF
MAC Clinical Research Leeds
Leeds, LS10 1DU
MAC Clinical Research Liverpool
Liverpool, L34 1BH
Re:Cognition Health London
London, W1G 9JF
St. Pancras Clinical Research
London, WC1X 8QD
MAC Clinical Research Manchester
Manchester, M13 9NQ
Re:Cognition Health Plymouth
Plymouth, PL5 8BT
5 Boroughs/North West Boroughs Healthcare NHS Foundation Trust
Warrington, WA22 8WA
Czechia5 sites
Neuro HK, s.r.o. POLIKLINIKA CHOCEŇ, a.s.
Choceň, 565 01
Cerebrovaskulární poradna s.r.o.
Moravská Ostrava, 702 00
Clintrial S.R.O
Prague, 100 00
Private Psychiatric Centre
Prague, 109 00
Vestra Clinics S.R.O
Rychnov nad Kněžnou, 516 01
Denmark3 sites
CCBR Clinical Research, Aalborg
Aalborg, DK-9000
CCBR Clinical Research, Ballerup
Ballerup Municipality, DK-2750
CCBR Clinical Research, Vejle
Vejle, DK-7100
Netherlands3 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ
Alzheimer Research Center
Amsterdam, 1081 GM
Amphia Ziekhuis
Breda, 4817 CK
About this study
Official title: A Double-Blind, Placebo-Controlled Proof-of-Concept Study of a Selective p38 MAP Kinase Alpha Inhibitor, Neflamapimod, Administered for 24 Weeks in Subjects With Mild Alzheimer's Disease
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.
Read the detailed description
Details provided elsewhere.
- Conditions
- Alzheimer Disease
- Being tested
- neflamapimod, placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neflamapimodDrug
Also called VX-745
40 mg neflamapimod capsule
placeboOther
matching placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| neflamapimod | Experimental | 40 mg hard gelatin capsules, taken twice daily with food. Receives: Drug: neflamapimod |
| placebo | Placebo comparator | hard gelatin capsules containing excipients only, weight- and size-matched; taken twice daily with food. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and Delayed Recall on the Hopkins Verbal Learning Test - Revised (HVLT-R)
Combined change from baseline in z-scores of total and delayed recall on the Hopkins Verbal Learning Test - Revised (HVLT-R) in neflamapimod-treated subjects compared to placebo. The primary endpoint was analyzed using Mixed Model for Repeated Measures (MMRM) with fixed effects for treatment, background AD-specific therapy, CDR-Global Score of 0.5 versus 1.0, scheduled visit (nominal) and scheduled visit by treatment interaction, random effect for subject and baseline Z-score as a covariate.
For baseline total and delayed recall, a z-score for each subject is defined by z=(x-m)/s where x is the subject's recall at baseline, and m and s are the overall mean and overall standard deviation of recall at baseline across all subjects. A composite baseline z-score for each subject is calculated using equal weighting in the following way: Z=0.5*z-score for total recall at baseline + 0.5*z-score for delayed recall at baseline. For HVLT-R, higher score indicates improvement.
Measured: Baseline and 24 weeks
Secondary outcomes (10)
Wechsler Memory Scale (WMS) Immediate and Delayed Recall
Change from baseline in Wechsler Memory Scale(WMS) immediate and delayed recall composites in neflamapimod-treated subjects compared to placebo. WMS scores were analyzed using Mixed Model for Repeated Measures (MMRM) with fixed effects for treatment, background AD-specific therapy, CDR-Global Score of 0.5 versus 1.0, scheduled visit (nominal) and scheduled visit by treatment interaction, random effect for subject and baseline Z-score as a covariate. Composite scores for immediate and delayed recall are the combination of all immediate and delayed recall task raw scores and ranges from 0-228. A higher score indicates improvement.
The following tests in WMS are done both for immediate and delayed recall: Logical Memory test, in which subject is read a story; Verbal-Paired Associates, in which subject is given pairs of words and asked remember which words go together; and Visual Reproduction, in which subject is given drawings of specific shapes
Measured: Baseline and 24 weeks
Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
Change from baseline in total score of Clinical Dementia Rating Scale - Sum of Boxes (range 0-18) in neflamapimod-treated subjects compared to placebo. CDR-SB scores were analyzed using Mixed Model for Repeated Measures (MMRM) with fixed effects for treatment, background AD-specific therapy, CDR-Global Score of 0.5 versus 1.0, scheduled visit (nominal) and scheduled visit by treatment interaction, random effect for subject and baseline Z-score as a covariate. CDR-SB score is calculated by adding the individual scores from 6 domains, Memory, Orientation, Judgement and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB scores range from 0-18, where a lower score indicates improvement. The scale is administered in a semi-structured interview format with both the patient and the caregiver/informant.
Measured: Baseline and 24 weeks
Mini-Mental State Examination (MMSE)
Changes from baseline in Mini-Mental State Examination (MMSE) scores were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value. The MMSE is scored from 0-30 with a higher score indicating improvement. The MMSE includes questions that test orientation, attention, memory, language and visual-spatial skills.
Measured: Baseline and 26 Weeks (Follow-up visit, 2 weeks from end of dosing)
Cerebrospinal Fluid Total Tau
Change from, baseline in Total Tau (t-tau) were compared using an ANCOVA with treatment group, background ADspecific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value.
Measured: Baseline and 24 weeks
Cerebrospinal Fluid Phospho-tau
Change from baseline in Phospho-Tau (p-tau181) were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value.
Measured: Baseline and 24 weeks
Cerebrospinal Fluid Amyloid Beta 1-40
Change from baseline in Amyloid beta (AB1-40) were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value.
Measured: Baseline and 24 weeks
Cerebrospinal Fluid Amyloid Beta 1-42
Change from baseline in Amyloid beta (AB1-42) were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value.
Measured: Baseline and 24 weeks
Cerebrospinal Fluid Neurogranin
Change from baseline in Neurogranin were compared using an ANCOVA with treatment group, background ADspecific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value.
Measured: Baseline and 24 weeks
Cerebrospinal Fluid Neurofilament Light Chain
Change from baseline in Neurofilament Light Chain (NFL) were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value.
Measured: Baseline and 24 weeks
Cerebrospinal Fluid P-tau/AB1-42 Ratio
Changes in the ratio of Phospho-Tau/Amyloid Beta (p-tau181/AB1-42) were compared using an ANCOVA with treatment group, background AD-specific therapy, CDR-Global Score as main effects and the baseline assessment as the covariate. The results of the ANCOVA are summarized using the treatment groups' least square means, the difference between the treatment groups' least square means, the 95% confidence interval for the treatment group difference and the p-value.
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start29 Dec 2017
- Primary completion30 Jun 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- EIP Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials, Amsterdam UMC, location VUmc
- Responsible party
- Sponsor
- Investigators
- John Alam, MD, Study director, EIP Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402659
- Sponsor's protocol ID
- EIP-VX17-745-304
- Acronym
- REVERSE-SD
- Status last verified
- Sep 2021
- First submitted
- 11 Jan 2018
- Last updated
- 27 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prins ND, Harrison JE, Chu HM, Blackburn K, Alam JJ, Scheltens P; REVERSE-SD Study Investigators. A phase 2 double-blind placebo-controlled 24-week treatment clinical study of the p38 alpha kinase inhibitor neflamapimod in mild Alzheimer's disease. Alzheimers Res Ther. 2021 May 27;13(1):106. doi: 10.1186/s13195-021-00843-2.
PubMed 34044875Tormahlen 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.
PubMed 33974419
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Proof-of-Concept Study of a Selective p38 MAP Kinase Alpha Inhibitor, Neflamapimod, Administered for 24 Weeks in Subjects With Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03402659
- Acronym / sponsor ID
- REVERSE-SD / EIP-VX17-745-304
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- EIP Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials, Amsterdam UMC, location VUmc
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Posted 27 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Details provided elsewhere.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| neflamapimod | Experimental | Drug: neflamapimod40 mg hard gelatin capsules, taken twice daily with food. |
| placebo | Placebo comparator | Other: placebohard gelatin capsules containing excipients only, weight- and size-matched; taken twice daily with food. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neflamapimodAlso: VX-74540 mg neflamapimod capsule | Drug | neflamapimod |
| placebomatching placebo capsule | Other | placebo |
Primary outcome
Total and Delayed Recall on the Hopkins Verbal Learning Test - Revised (HVLT-R)
Time frame: Baseline and 24 weeks
Combined change from baseline in z-scores of total and delayed recall on the Hopkins Verbal Learning Test - Revised (HVLT-R) in neflamapimod-treated subjects compared to placebo. The primary endpoint was analyzed using Mixed Model for Repeated Measures (MMRM) with fixed effects for treatment, background AD-specific therapy, CDR-Global Score of 0.5 versus 1.0, scheduled visit (nominal) and scheduled visit by treatment interaction, random effect for subject and baseline Z-score as a covariate. For baseline total and delayed recall, a z-score for each subject is defined by z=(x-m)/s where x is the subject's recall at baseline, and m and s are the overall mean and overall standard deviation of recall at baseline across all subjects. A composite baseline z-score for each subject is calculated using equal weighting in the following way: Z=0.5*z-score for total recall at baseline + 0.5*z-score for delayed recall at baseline. For HVLT-R, higher score indicates improvement.
10 secondary outcomes
Wechsler Memory Scale (WMS) Immediate and Delayed Recall
Time frame: Baseline and 24 weeks
Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
Time frame: Baseline and 24 weeks
Mini-Mental State Examination (MMSE)
Time frame: Baseline and 26 Weeks (Follow-up visit, 2 weeks from end of dosing)
Cerebrospinal Fluid Total Tau
Time frame: Baseline and 24 weeks
Cerebrospinal Fluid Phospho-tau
Time frame: Baseline and 24 weeks
Cerebrospinal Fluid Amyloid Beta 1-40
Time frame: Baseline and 24 weeks
Cerebrospinal Fluid Amyloid Beta 1-42
Time frame: Baseline and 24 weeks
Cerebrospinal Fluid Neurogranin
Time frame: Baseline and 24 weeks
Cerebrospinal Fluid Neurofilament Light Chain
Time frame: Baseline and 24 weeks
Cerebrospinal Fluid P-tau/AB1-42 Ratio
Time frame: Baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34044875Prins ND, Harrison JE, Chu HM, Blackburn K, Alam JJ, Scheltens P; REVERSE-SD Study Investigators. A phase 2 double-blind placebo-controlled 24-week treatment clinical study of the p38 alpha kinase inhibitor neflamapimod in mild Alzheimer's disease. Alzheimers Res Ther. 2021 May 27;13(1):106. doi: 10.1186/s13195-021-00843-2.
- Derived from this study: PubMed 33974419Tormahlen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Alam, MD study director
EIP Pharma
38 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing neflamapimod in people with Alzheimer Disease, run by EIP Pharma Inc at 38 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, United Kingdom, Czechia, Denmark, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total and Delayed Recall on the Hopkins Verbal Learning Test - Revised (HVLT-R) (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03402659, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.