XPro1595 for Alzheimer's Disease

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called XPro1595 to determine its safety and effectiveness for people with Alzheimer's Disease. The goal is to assess its impact on memory, daily functioning, and brain health over the long term. This follow-up study targets individuals who have completed a previous XPro1595 study. Ideal participants are those who finished the earlier study, manage their Alzheimer's or related symptoms with stable medications, and have a caregiver to assist during the trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that XPro1595 is likely to be safe for humans?

Research has shown that XPro1595 is well-tolerated in studies with Alzheimer's patients. One study found it safe even for those at higher risk due to the ApoE4 genetic marker. Importantly, no cases of brain swelling or bleeding occurred. An independent committee regularly reviewed safety data to ensure participants' well-being. While more information from published studies would be helpful, current findings suggest XPro1595 is generally safe for human use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

XPro1595 is unique because it targets inflammation in the brain, which is a different approach compared to most Alzheimer's treatments that focus on neurotransmitter regulation. Researchers are excited about XPro1595 because it aims to neutralize a specific inflammatory protein called tumor necrosis factor (TNF), potentially slowing disease progression more effectively. This innovative mechanism of action could offer new hope for patients by addressing the underlying causes of Alzheimer's rather than just managing symptoms.

What evidence suggests that XPro1595 might be an effective treatment for Alzheimer's Disease?

Research has shown that XPro1595, a treatment targeting specific harmful proteins, may help with Alzheimer's disease. In earlier studies, patients who took XPro1595 showed improvements in memory and thinking skills. The data also suggests it can improve important markers of brain health. This treatment reduces inflammation in the brain, a major issue in Alzheimer's. Early findings indicate it can benefit patients of various ages. These results make XPro1595 a promising option for those with Alzheimer's. ^{1 2 3 4 6}

Who Is on the Research Team?

Tara Lehner

Principal Investigator

INmune Bio

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. inmunebio.com inmunebio.com/index.php/newsroom/2025-news/muneioeportseyindingsfromhase2urialo20250630043503

INmune Bio Reports Key Findings from Phase 2 MINDFuL ... “Our findings indicate that XPro™ may offer benefits to Alzheimer's patients across all age groups, regardless of comorbidities, additional ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05522387

An Open-Label Extension of XPro1595 in Patients With ... This study is designed as a Phase 2, open label study investigating the safety, tolerability, and efficacy of XPro1595 in patients with Alzheimer's Disease ...

3. medrxiv.org medrxiv.org/content/10.1101/2025.09.24.25336496v1.full-text

XPro1595, a Selective Soluble TNF Neutralizer, in Early ... XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer's Disease with Inflammation (ADi): Results from the Phase 2 MINDFuL Trial.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05318976

NCT05318976 | A Study of XPro1595 in Patients With Early ... The goal of this Phase 2 Alzheimer's study is to determine whether 1.0 mg/kg XPro1595 confers a benefit on cognition, function, and biomarkers of white ...

5. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/XPro1595_UPDATE_%28drug_in_development%29.pdf

XPro1595 Safety and efficacy will be determined when data from clinical trials become available. Neuroprotective Benefit: XPro1595 treatment improved cognitive function ...

6. psychiatrictimes.com psychiatrictimes.com/view/xpro1595-in-early-alzheimer-disease-with-inflammation-phase-2-mindful-trial-results-submitted-for-publication

XPro1595 in Early Alzheimer Disease With Inflammation XPro demonstrated consistent positive trends across cognitive, neuropsychiatric, and biological endpoints, which suggests that targeting ...