An Open-Label Extension of XPro1595 in Patients With Alzheimer's Disease

  • STATUS
    Recruiting
  • End date
    Dec 4, 2025
  • participants needed
    261
  • sponsor
    Inmune Bio, Inc.
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Updated on 7 October 2022
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alzheimer's disease
cognitive assessment

Summary

The goal of this Phase 2 Open-Label Extension (OLE) is to evaluate long-term safety, tolerability, and efficacy of XPro1595 on measures of cognition, function and brain quality in individuals with mild Alzheimer's Disease or MCI with biomarkers of inflammation.

Description

This study is designed as a Phase 2, open-label study investigating the safety, tolerability, and efficacy of XPro1595 in patients with Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI). The planned dose is 1.0 mg/kg of XPro1595 for all subjects that completed a previous Phase 2 study with XPro1595.

There are two Phase 2 Studies that were previously set up, whose participants can subsequently join this OLE study. One Phase 2 Study (NCT05318976) is a randomized, placebo-controlled, double-blind clinical study where 201 (anticipated) participants receive XPro1595 and placebo (2:1 ratio) for 6 months (Week 1 to Week 24). This study targets patients with mild Alzheimer's Disease (AD). Participants who received the drug during this study, and subsequently join the OLE study, will be on XPro1595 for an additional 12 months (52 weeks). Their total exposure to XPro1595 will be up to 18 months (76 weeks).

The other Phase 2 Study (NCT05321498) is a randomized, placebo-controlled, double-blind clinical study where 60 (anticipated) participants receive XPro1595 and placebo (2:1 ratio) for 3 months (Week 1 to Week 12). This study targets patients with Mild Cognitive Impairment (MCI). Participants who received the drug during this study, and subsequently join the OLE study, will be on XPro1595 for an additional 15 months (64 weeks). Their total exposure to XPro1595 will be up to 18 months (76 weeks).

Details
Condition Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders, Mild Cognitive Impairment (MCI)
Treatment XPro1595
Clinical Study IdentifierNCT05522387
SponsorInmune Bio, Inc.
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients are eligible to be included in the study only if all the following
criteria apply
Participated and completed the full duration of the study intervention and all procedures at the End of Study (EOS) visit in a previous XPro1595 Phase 2 study
Concomitant medications for the management MCI/AD and/or behavior symptoms which were ongoing during the double-blind study should remain at a constant dose throughout this study
Patient must be willing and able to provide informed consent prior to any study procedures being performed. If the patient is not competent, a LAR (Legally Authorized Representative) must provide informed consent on their behalf, and the patient must provide assent
Has a study partner willing to participate for the duration of the trial who either lives in the same household or interacts with the patient at least 4 hours per day and on at least 4 days per week, who is knowledgeable about the patient's daytime and night-time behaviors and who can be available to attend all clinic visits in person at which informant assessments are performed. This study partner should agree to monitor and report on concomitant medications, understand the study requirements, and assist the participant in meeting study requirements. Patients with study partners that do not meet this criterion but are determined by the investigator as able to provide an adequate assessment of the patient may also participate with prior approval from the sponsor
Male contraception - Agree to use a male condom with female partner use of an additional highly effective contraceptive method with a failure rate of < 1% per year
A female participant who is a woman of child-bearing potential (WOBCP) must have a negative highly sensitive pregnancy test (urine) as required by local regulations within 24 hours before the first dose of study intervention, see Section 7.3.6

Exclusion Criteria

Any clinically significant abnormalities that in the opinion of the Investigator require further investigation or treatment or may interfere with study procedures and assessments or affect patient safety. These include but are not limited to, laboratory tests, electrocardiogram (ECG), physical examination, or vital signs at Screening or other medical conditions (e.g., cardiac, respiratory, gastrointestinal, psychiatric, renal disease) which are not adequately and stably controlled
Unable to comply with the study procedures and assessments
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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