Dementia With Lewy BodiesPhase 2NCT05869669
RewinD-LB - Clinical Study of Neflamapimod in Patients With Dementia With Lewy Bodies
A Phase 2 study testing Neflamapimod in people with Dementia With Lewy Bodies, run by EIP Pharma Inc at 40 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether neflamapimod can improve learning skills, problem solving skills, and memory loss in people diagnosed with DLB. More specifically, improvement in verbal learning, memory, and attention, as well as cognitive and functional performance will be measured. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dementia With Lewy Bodies
- 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
- 159 participants
- Where
- 40 sitesin 3 countries
- Study dates
- 1 May 2023to 16 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged ≥55 years.
- Subject or subject's legally authorized representative is willing and able to provide written informed consent.
- 3. Probable DLB by consensus criteria (McKeith et al, 2017), including a positive DaTscan™. Specifically, the subject must have the presence of dementia in association with:
- At least two (2) core clinical features (fluctuating cognition, visual hallucinations, REM sleep disorder, and/or parkinsonism); or
- One (1) core clinical feature plus an abnormal DaTscan™. Historical polysomnography (PSG)-verified REM sleep behavioral disorder (RBD), FDG-PET imaging, or MIBG myocardial scintigraphy can take the place of an abnormal DaTscan™ in a patient with only one core clinical feature.
- CDR Global Score 0.5 (very mild dementia) or 1.0 (mild dementia) during Screening
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- Background dementia therapy:
- Not currently receiving cholinesterase inhibitor therapy. If the patient received such therapy previously, that therapy must have been discontinued at least 3 months prior to randomization.
- Receiving cholinesterase inhibitor therapy alone. If the patient is currently receiving cholinesterase inhibitor therapy, the patient must have received such therapy for greater than 3 months and on a stable dose for at least 6 weeks at the time of randomization. Except for reducing the dose for tolerability reasons, the dose of cholinesterase inhibitor may not be modified during the study.
- Memantine therapy is allowed, if it had been started at least 3 months prior to randomization and the patient is also receiving cholinesterase inhibitor therapy. If the patient has never been on cholinesterase inhibitor therapy (naïve), then memantine monotherapy is allowed.
- Normal or corrected eyesight and auditory abilities, sufficient to perform all aspects of the cognitive and functional assessments.
- No history of learning difficulties that may interfere with their ability to complete the cognitive tests.
- Received vaccination for SARS-CoV-19 unless medical contraindications prevent being vaccinated, or has a history of natural infection.
- Must have reliable informant or caregiver.
Who cannot join
- Diagnosis of any other ongoing central nervous system (CNS) condition other than DLB, including, but not limited to, post-stroke dementia, vascular dementia, Alzheimer's disease (AD), or Parkinson's disease (PD).
- Plasma ptau181 result above the threshold that indicates evidence of pathology associated with Alzheimer's disease at Screening.
- 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 C-SSRS, or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide.
- Ongoing major and active psychiatric disorder and/or other concurrent medical condition that, 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.
- Poorly controlled clinically significant medical illness, such as hypertension (blood pressure >180 mmHg systolic or 100 mmHg diastolic); myocardial infarction within 6 months; uncompensated congestive heart failure or other significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would interfere with assessment of drug safety.
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- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 × the upper limit of normal (ULN), total bilirubin >1.5 × ULN, and/or International Normalized Ratio (INR) >1.5. If patient is taking blood thinners (e.g., warfarin), and has no known liver issues, INR >3.
- Known human immunodeficiency virus, hepatitis B, or active hepatitis C virus infection.
- Participated in a study of an investigational drug less than six weeks or 5 half-lives of an investigational drug, whichever is longer, before enrollment in this study.
- History of previous neurosurgery to the brain within the past five years.
- If male with female partner(s) of child-bearing potential, unwilling or unable to adhere to contraception requirements specified in the protocol.
- If female who has not has not reached menopause >1 year previously or has not had a hysterectomy or bilateral oophorectomy/salpingo-oophorectomy, has a positive pregnancy test result during Screening and/or is unwilling or unable to adhere to the contraception requirements specified in the protocol.
- Weight less than 50kg.
- All participants who complete the initial 16-week period of the study will be able to continue in the study and receive neflamapimod for an additional 32 weeks (8 months) regardless of whether they received neflamapimod of placebo during the the first 16 weeks.
Trial locations and contacts
40 sites in 3 countries.
40 sites in 3 countries
United States29 sites
Sana Research
Arlington, Virginia, 22205
University of Colorado - Dept of Neurology
Aurora, Colorado, 80045
Johns Hopkins School of Medicine - Dept of Neurology
Baltimore, Maryland, 21287
NeuroScience Research Center
Canton, Ohio, 44718
University of North Carolina - Dept of Neurology
Chapel Hill, North Carolina, 27599
Mass General Hospital/Harvard Medical School - Dept of Neurology
Charlestown, Massachusetts, 02129
Cleveland Clinic - Center for Brain Health
Cleveland, Ohio, 44195
Ohio State University - Dept of Neurology
Columbus, Ohio, 43221
Houston Methodist Hospital - Stanley Appel Neurology Dept
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160
UCSD Health Sciences - Movement Disorders Center
La Jolla, California, 92037
JEM Research Institute
Lake Worth, Florida, 33462
Cleveland Clinic - Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106
Tandem Clinical Research
Marrero, Louisiana, 70072
ClinCloud
Melbourne, Florida, 32940
Columbia University - Taub Institute/Neurology Dept
New York, New York, 10032
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
University of Nebraska Medical Center - Dept of Neurological Sciences
Omaha, Nebraska, 68198
AdventHealth Neuroscience Research
Orlando, Florida, 32804
Stanford Neuroscience Health Center
Palo Alto, California, 94304
SC3 Research Group
Pasadena, California, 91105
Panhandle Research and Medical Clinic
Pensacola, Florida, 32503
Barrow Neurological Institute
Phoenix, Arizona, 85013
Center for Cognitive Health
Portland, Oregon, 97225
Virginia Commonwealth University - Parkinson's and Movement Disorders Center
Richmond, Virginia, 23298
Mayo Clinic - Alzheimer's Disease Research Center
Rochester, Minnesota, 55905
Banner Sun Health Research Institute
Sun City, Arizona, 85351
Banner Alzheimer's Institute - Edson Family Lewy Body Dementia Center
Tucson, Arizona, 85718
Georgetown Univ Hospital - Dept of Neurology
Washington D.C., District of Columbia, 20007
United Kingdom8 sites
Belfast Health & Social Care Trust
Belfast, BT12 6BA
Cambridgeshire and Peterborough NHS Foundation Trust, Fulbourn Hospital - Windsor Research Unit
Cambridge, CB215EF
South London and Maudsley NHS Foundation Trust
London, SE5 8AF
Re:Cognition Health
London, W1G9JF
University College London (UCL) Clinical Research Facility, University College London Hospitals NHS Foundation Trust
London, WC1N 3BG
Campus Ageing Research Unit (CARU) - Newcastle upon Tyne, CNTW NHS Foundation Trust
Newcastle upon Tyne, NE4 5PL
Cornwall Partnership NHS Foundation Trust (University of Exeter)
Redruth, TR15 3QE
Memory Assessment and Research Centre (MARC) - Moorgreen Hospital
Southampton, SO30 3JB
Netherlands3 sites
Brain Research Center - Den Bosch
's-Hertogenbosch, 5223
Brain Research Center - Amsterdam
Amsterdam, 1081
Brain Research Center - Zwolle
Zwolle, 8025
About this study
Official title: A Phase 2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients With Dementia With Lewy Bodies
The purpose of this study is to determine whether neflamapimod can improve learning skills, problem solving skills, and memory loss in people diagnosed with DLB. More specifically, improvement in verbal learning, memory, and attention, as well as cognitive and functional performance will be measured.
Read the detailed description
This study includes a 16-week blinded treatment period (randomized 1:1 neflamapimod:placebo) and a 32 week open-label extension during which all participants receive neflamapimod.
- Conditions
- Dementia With Lewy Bodies
- Being tested
- Neflamapimod, Placebo
- Keywords
- DLB
- Medical subject headings
- Lewy Body 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
Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules
PlaceboDrug
Placebo is a capsule that looks just like neflamapimod but without the active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Neflamapimod | Active comparator | Neflamapimod will be administered with food for 16 weeks in participants with DLB. Participants will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals). Receives: Drug: Neflamapimod |
| Placebo | Placebo comparator | Placebo will be administered with food for 16 weeks in participants with DLB. Participants will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals). Receives: Drug: Placebo |
| Open-label extension | Experimental | Neflamapimod will be administered with food for 32 weeks in participants with DLB who have completed the blinded treatment period. Participants will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals). Receives: Drug: Neflamapimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)
Evaluate the efficacy of neflamapimod, compared to placebo, as a treatment for DLB, as assessed by the CDR-SB scale.
CDR-SB scores range from 0 to 18 with a higher score indicating worsening of cognitive impairment.
Measured: 16 weeks
Secondary outcomes (3)
Change in Timed Up and Go Test (TUG) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)
Evaluate if neflamapimod improves motor function in participants with DLB, compared to placebo, as assessed by the TUG test.
TUG scores typically range from 6 to 20 seconds with a higher score indicating worse mobility. A score of >15 indicates an increased risk of falls.
Measured: 16 weeks
Change in the Composite Score of the Neuropsychological Test Battery (NTB), Including Tests of Attention, Executive Function, and Visual Learning in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)
Evaluate if neflamapimod improves cognition, compared to placebo, as assessed by a DLB-specific NTB in participants with DLB. NTB includes Cogstate Detection test (DET), Cogstate Identification test (IDN), Cogstate One Card Learning test (OCL), Cogstate One Back test (ONB).
Each score on the individual tests is converted to a z-score, and then a total z-score for the composite is calculated, in which each test is weighted equally. As the analysis is based on z-scores, there is no minimum or maximum value. A z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in z-score indicates an improvement in cognition and a negative change in z-score indicates a worsening in cognition.
Measured: 16 weeks
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-GCIC) Score at Week 16 in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)
Evaluate if neflamapimod improves global (cognition, function and behavior) disease status evaluated by a clinician with caregiver input, compared to placebo, in participants with DLB, as assessed ADCS-CGIC score.
ADCS-CGIC scores range from 1 to 7, where 1 = marked improvement, 2= moderate improvement, 3 = minimal improvement, 4 = no change, 5 = minimal worsening, 6 = moderate worsening, and 7 = marked worsening.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 May 2023
- Primary completion29 May 2025
- Study completion16 Jun 2025
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 (1)Papers the sponsor has linked to this study.
- Other trials for Dementia With Lewy BodiesStudies 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
- Phase 2b (hypothesis-testing), multi-center, randomized, double-blind, placebo-controlled study with an open-label extension
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- EIP Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Worldwide Clinical Trials, CervoMed, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869669
- Sponsor's protocol ID
- EIP21-NFD-504
- Other IDs
- R01AG080536, 2023-504373-20, 2023
- Status last verified
- Aug 2026
- First submitted
- 12 Apr 2023
- Last updated
- 3 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prins ND, de Haan W, Gardner A, Blackburn K, Chu HM, Galvin JE, Alam JJ. Phase 2A Learnings Incorporated into RewinD-LB, a Phase 2B Clinical Trial of Neflamapimod in Dementia with Lewy Bodies. J Prev Alzheimers Dis. 2024;11(3):549-557. doi: 10.14283/jpad.2024.36.
PubMed 38706271
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients With Dementia With Lewy Bodies
- ClinicalTrials.gov ID
- NCT05869669
- Acronym / sponsor ID
- EIP21-NFD-504
- Conditions
- Dementia With Lewy Bodies
- Keywords
- DLB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- EIP Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Worldwide Clinical Trials, CervoMed, Inc.
- Study start
- 1 May 2023 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Posted 3 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether neflamapimod can improve learning skills, problem solving skills, and memory loss in people diagnosed with DLB. More specifically, improvement in verbal learning, memory, and attention, as well as cognitive and functional performance will be measured.
Detailed description
This study includes a 16-week blinded treatment period (randomized 1:1 neflamapimod:placebo) and a 32 week open-label extension during which all participants receive neflamapimod.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Phase 2b (hypothesis-testing), multi-center, randomized, double-blind, placebo-controlled study with an open-label extension
| Arm | Type | Receives |
|---|---|---|
| Neflamapimod | Active comparator | Drug: NeflamapimodNeflamapimod will be administered with food for 16 weeks in participants with DLB. Participants will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered with food for 16 weeks in participants with DLB. Participants will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals). |
| Open-label extension | Experimental | Drug: NeflamapimodNeflamapimod will be administered with food for 32 weeks in participants with DLB who have completed the blinded treatment period. Participants will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals). |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Men and women aged ≥55 years.
- Subject or subject's legally authorized representative is willing and able to provide written informed consent.
- 3. Probable DLB by consensus criteria (McKeith et al, 2017), including a positive DaTscan™. Specifically, the subject must have the presence of dementia in association with:
- CDR Global Score 0.5 (very mild dementia) or 1.0 (mild dementia) during Screening
- Background dementia therapy:
Key exclusion criteria (14 listed)
- Diagnosis of any other ongoing central nervous system (CNS) condition other than DLB, including, but not limited to, post-stroke dementia, vascular dementia, Alzheimer's disease (AD), or Parkinson's disease (PD).
- Plasma ptau181 result above the threshold that indicates evidence of pathology associated with Alzheimer's disease at Screening.
- 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 C-SSRS, or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide.
- Ongoing major and active psychiatric disorder and/or other concurrent medical condition that, 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.
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-745Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules | Drug | Neflamapimod, Open-label extension |
| PlaceboPlacebo is a capsule that looks just like neflamapimod but without the active ingredients | Drug | Placebo |
Primary outcome
Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)
Time frame: 16 weeks
Evaluate the efficacy of neflamapimod, compared to placebo, as a treatment for DLB, as assessed by the CDR-SB scale. CDR-SB scores range from 0 to 18 with a higher score indicating worsening of cognitive impairment.
3 secondary outcomes
Change in Timed Up and Go Test (TUG) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)
Time frame: 16 weeks
Change in the Composite Score of the Neuropsychological Test Battery (NTB), Including Tests of Attention, Executive Function, and Visual Learning in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)
Time frame: 16 weeks
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-GCIC) Score at Week 16 in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38706271Prins ND, de Haan W, Gardner A, Blackburn K, Chu HM, Galvin JE, Alam JJ. Phase 2A Learnings Incorporated into RewinD-LB, a Phase 2B Clinical Trial of Neflamapimod in Dementia with Lewy Bodies. J Prev Alzheimers Dis. 2024;11(3):549-557. doi: 10.14283/jpad.2024.36.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 3 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 Dementia With Lewy Bodies, run by EIP Pharma Inc at 40 sites in 3 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 14 inclusion and 14 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 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, United Kingdom, 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 3 Sep 2026). 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?
Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period) (time frame: 16 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 NCT05869669, which also lists 1 linked publication.
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 3 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.