XPro1595 for Alzheimer's Disease

Recruiting at 5 trial locations

Overseen By INmune Bio, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Inmune Bio, Inc.

Must be taking: MCI/AD medications

Disqualifiers: Uncontrolled cardiac, respiratory, psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 55 to 74 weeks

11 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests XPro1595, a drug for Alzheimer's Disease, on people who were in previous studies. It aims to see if regular injections can reduce brain inflammation and improve memory and daily activities.

Do I need to stop my current medications for the trial?

No, you don't need to stop your current medications. In fact, if you are taking medications for Alzheimer's or related symptoms, you should keep taking them at the same dose during the trial.

How is the drug XPro1595 different from other Alzheimer's treatments?

XPro1595 is unique because it targets neuroinflammation, a key factor in Alzheimer's disease, by inhibiting a specific protein called tumor necrosis factor (TNF). This approach is different from many existing treatments that primarily focus on reducing amyloid plaques in the brain. ^{1 2 3 4 5}

Research Team

Tara Lehner

Principal Investigator

INmune Bio

Eligibility Criteria

This trial is for individuals who completed a previous XPro1595 study for Alzheimer's, can consent (or have a representative do so), and have a partner to assist them. They must maintain stable doses of current Alzheimer's medications and agree to contraception if applicable. Those with unstable medical conditions or unable to follow the study plan are excluded.

Inclusion Criteria

My medications for mild cognitive impairment or Alzheimer's disease will stay the same during this study.

All females of childbearing potential (FCBP) must have a negative urine pregnancy test and agree to use a highly effective method of contraception during the treatment period and 30 days after the last dose of treatment

Participated and completed the full duration of the study intervention and all procedures at the End of Study (EOS) visit in a previous XPro1595 study

Exclusion Criteria

I can follow the study's procedures and assessments.

I don't have any health issues that could affect my safety in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1.0 mg/kg of XPro1595 as a subcutaneous injection once a week

55 to 74 weeks

Weekly visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue receiving XPro1595 to evaluate long-term safety, tolerability, and efficacy

Up to 78 weeks

Treatment Details

Interventions

• XPro1595

Trial Overview The Phase 2 trial tests the long-term safety and effectiveness of XPro1595 on cognitive function, daily activities, and brain health in people with Alzheimer's Disease. It’s an open-label extension meaning everyone gets the drug and there’s no placebo comparison.

Participant Groups

Group I: Experimental: 1.0 mg/kg XPro1595 Experimental Treatment 1 Intervention

Patients will receive XPro1595.

Who Is Running the Clinical Trial?

Inmune Bio, Inc.

Lead Sponsor

Trials

7

Recruited

340+

Findings from Research

In an 11-week study involving 181 patients with mild to moderate Alzheimer's disease, the alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid modulator LY451395 did not show significant improvement in cognitive function compared to placebo, as measured by the ADAS-Cog scale.

While there were some marginal improvements in neuropsychiatric symptoms after 8 weeks of treatment, the overall safety profile was similar between LY451395 and placebo, with most adverse events being mild.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AMPA potentiator treatment of cognitive deficits in Alzheimer disease. Chappell, AS., Gonzales, C., Williams, J., et al.[2022]

AD16, a new drug candidate for Alzheimer's disease, showed a favorable safety and tolerability profile in a study involving 62 healthy Chinese adults, with no serious adverse events reported.

The pharmacokinetics of AD16 indicated that its absorption rate is slowed by high-fat meals, but this does not affect the overall absorption, suggesting it can be effectively administered regardless of meal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability, pharmacokinetics and effects of diet on AD16, a novel neuroinflammatory inhibitor for Alzheimer's disease: a randomized phase 1 study. Peng, D., Xu, S., Zou, T., et al.[2023]

LY2599666, a monoclonal antibody targeting soluble amyloid-β, demonstrated effective pharmacokinetics and pharmacodynamics in healthy subjects, with a model predicting its ability to suppress Aβ levels in plasma after subcutaneous dosing.

In a small cohort of Alzheimer's patients, the drug was administered weekly for 12 weeks, showing potential for crossing the blood-brain barrier, which is crucial for targeting amyloid-β in the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Pharmacodynamics of LY2599666, a PEG-Linked Antigen Binding Fragment that Targets Soluble Monomer Amyloid-β. Li, L., Zhen, EY., Decker, RL., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of APP 5-mer peptide analogue P165 on the synaptic proteins and insulin signal transduction proteins. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

AMPA potentiator treatment of cognitive deficits in Alzheimer disease. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Neurotrophic effects of amyloid precursor protein peptide 165 in vitro. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Safety, tolerability, pharmacokinetics and effects of diet on AD16, a novel neuroinflammatory inhibitor for Alzheimer's disease: a randomized phase 1 study. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Pharmacodynamics of LY2599666, a PEG-Linked Antigen Binding Fragment that Targets Soluble Monomer Amyloid-β. [2020]