Neflamapimod for Dementia

JEM Research Institute, Lake Worth, FL
DementiaNeflamapimod - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing if a drug can improve learning, problem solving, and memory in people with dementia with Lewy Bodies.

Eligible Conditions
  • Dementia with Lewy Bodies (DLB)

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 16 weeks

16 weeks
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-GCIC) score at Week 16 in neflamapimod-treated subjects compared to placebo recipients.
Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in neflamapimod-treated subjects compared to placebo recipients.
Change in Timed Up and Go Test (TUG) in neflamapimod-treated subjects compared to placebo recipients.
Change in the composite score of the Neuropsychological Test Battery (NTB), including tests of attention, executive function, and visual learning in neflamapimod-treated subjects compared to placebo recipients.
Exploratory outcome - 12-item Neuropsychiatric Inventory (NPI-12)
Exploratory outcome - Dementia Cognitive Fluctuations Scale (DCFS)
Exploratory outcome - EEG
Exploratory outcome - Movement Disorder Society - Unified Parkinson's Disease Rating Scale - Part III (MSD-UPDRS3) motor examination (Part III)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Neflamapimod
1 of 2
Placebo
1 of 2

Active Control

Non-Treatment Group

160 Total Participants · 2 Treatment Groups

Primary Treatment: Neflamapimod · Has Placebo Group · Phase 2

Neflamapimod
Drug
ActiveComparator Group · 1 Intervention: Neflamapimod · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks

Who is running the clinical trial?

EIP Pharma IncLead Sponsor
5 Previous Clinical Trials
299 Total Patients Enrolled
1 Trials studying Dementia
91 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,487 Previous Clinical Trials
5,129,147 Total Patients Enrolled
233 Trials studying Dementia
922,154 Patients Enrolled for Dementia
Worldwide Clinical TrialsOTHER
58 Previous Clinical Trials
14,019 Total Patients Enrolled
2 Trials studying Dementia
190 Patients Enrolled for Dementia

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

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Frequently Asked Questions

Is it possible to enroll in this scientific investigation at present?

"That is correct. According to clinicaltrials.gov, this medical trial was originally posted on May 1st 2023 and remains open for recruitment as of the 17th of May in the same year. Presently, 160 patients need to be recruited from only a single site." - Anonymous Online Contributor

Unverified Answer

How many individuals are currently enrolled in the trial?

"Affirmative. Clinicaltrials.gov affirms that this clinical trial is still seeking participants; the study was first posted on May 1st 2023 and subsequently edited on the 17th of the same month. The goal is to recruit 160 individuals from a single medical site." - Anonymous Online Contributor

Unverified Answer

Has Neflamapimod been sanctioned for medical use by the FDA?

"Our team has given Neflamapimod a score of 2 as the Phase 2 trial provides some proof that it is safe but does not provide any evidence that it is efficacious." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.