128 Participants Needed

PMN310 for Alzheimer's Disease

Recruiting at 21 trial locations
WL
Overseen ByWendy Luca
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: ProMis Neurosciences, Inc
Must be taking: Acetylcholinesterase inhibitors, Memantine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial allows patients to continue taking FDA-approved acetylcholinesterase inhibitors or memantine as long as the dose has been stable for at least 3 months before screening. However, if you are currently receiving anti-amyloid treatments, you must stop them at least 9 months before screening.

What data supports the effectiveness of the drug PMN310 for Alzheimer's Disease?

There is no direct data on PMN310, but research on similar treatments suggests that targeting specific pathways in Alzheimer's, like the calcineurin-Pin1 signaling cascade, has shown promise in reducing disease prevalence in other contexts.12345

How does the drug PMN310 for Alzheimer's disease differ from other treatments?

PMN310 is unique because it targets the p38 MAPK pathway, which is involved in regulating inflammation in the brain associated with Alzheimer's disease. This approach aims to reduce neuroinflammation and amyloid beta accumulation, which are key factors in the progression of Alzheimer's.26789

What is the purpose of this trial?

This Phase 1b study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of multiple IV infusions of PMN310 in patients with early Alzheimer's disease.

Eligibility Criteria

This trial is for individuals with early Alzheimer's disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a particular stage or severity of Alzheimer's.

Inclusion Criteria

Patient and caregiver provide written informed consent
I am 50 or older and can see and hear well enough to do tests.
I've been on a stable dose of medication for Alzheimer's for at least 3 months.
See 6 more

Exclusion Criteria

Pregnant or breastfeeding
Living in a continuous care or long-term care nursing facility
Negative PET scan with any amyloid-targeting ligand within 6 months of Screening or during Screening
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PMN310 or placebo once every 28 days for a total of 12 infusions

48 weeks
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Treatment Details

Interventions

  • PMN310
Trial Overview The study is testing PMN310, which is given through IV infusions to see if it's safe and can help patients with early Alzheimer's. It will also compare results against a placebo group that receives no active drug.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Cohort 3 PMN310 1400 mg or placeboExperimental Treatment2 Interventions
PMN310 1400 mg or placebo administered as a 60-minute infusion.
Group II: Cohort 2 PMN310 700 mg or placeboExperimental Treatment2 Interventions
PMN310 700 mg or placebo administered as a 60-minute infusion.
Group III: Cohort 1 PMN310 350 mg or placeboExperimental Treatment2 Interventions
PMN310 350 mg or placebo administered as a 60-minute infusion.

Find a Clinic Near You

Who Is Running the Clinical Trial?

ProMis Neurosciences, Inc

Lead Sponsor

Trials
2
Recruited
170+

Findings from Research

In a study involving 41 Alzheimer disease patients, acupuncture alone showed a significant improvement in cognitive function (measured by MMSE) compared to a combination of acupuncture and music therapy.
While both treatments improved patient outcomes, acupuncture alone was found to be more effective than the combination therapy, suggesting that acupuncture may be a stronger intervention for enhancing therapeutic effects in Alzheimer's disease.
[Clinical observation on acupuncture combined with music for treatment of Alzheimer disease].Liu, G., Yuan, LX.[2018]
In a preliminary study of 16 patients with early Alzheimer's disease, the p38α kinase inhibitor neflamapimod showed potential to improve episodic memory function, with significant increases in memory scores observed at 28 and 84 days.
While there were no overall group effects on brain amyloid plaque load, a responder analysis indicated that some patients experienced a reduction in amyloid signal, suggesting a possible impact on β-amyloid production that warrants further investigation.
An exploratory clinical study of p38α kinase inhibition in Alzheimer's disease.Scheltens, P., Prins, N., Lammertsma, A., et al.[2022]
Tacrolimus (FK506), an FDA-approved calcineurin inhibitor, can be safely delivered to APP/PS1 mice using time-release pellets, leading to normalization of calcineurin activity and significant reduction of Alzheimer's disease (AD) pathologies such as synapse loss and neuroinflammation.
The treatment with FK506 not only alleviated cognitive impairment and neuroinflammation but also preserved normal immune responses, suggesting it could be a promising early intervention for Alzheimer's disease.
Long-term normalization of calcineurin activity in model mice rescues Pin1 and attenuates Alzheimer's phenotypes without blocking peripheral T cell IL-2 response.Stallings, NR., O'Neal, MA., Hu, J., et al.[2023]

References

[Clinical observation on acupuncture combined with music for treatment of Alzheimer disease]. [2018]
An exploratory clinical study of p38α kinase inhibition in Alzheimer's disease. [2022]
Long-term normalization of calcineurin activity in model mice rescues Pin1 and attenuates Alzheimer's phenotypes without blocking peripheral T cell IL-2 response. [2023]
A 24-week open-label extension study of memantine in moderate to severe Alzheimer disease. [2022]
Drugs in Clinical Trials for Alzheimer's Disease: The Major Trends. [2018]
p38 MAPK Is a Major Regulator of Amyloid Beta-Induced IL-6 Expression in Human Microglia. [2023]
APP-C31: An Intracellular Promoter of Both Metal-Free and Metal-Bound Amyloid-β40 Aggregation and Toxicity in Alzheimer's Disease. [2023]
Early chronic suppression of microglial p38α in a model of Alzheimer's disease does not significantly alter amyloid-associated neuropathology. [2023]
The PSEN1, p.E318G variant increases the risk of Alzheimer's disease in APOE-ε4 carriers. [2022]
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