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

• Status: Recruiting
• Trial end date: 2025-12-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inmune Bio, Inc.

Criteria

Inclusion Criteria:

Patients are eligible to be included in the study only if all the following criteria apply:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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:

1. 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.

2. Unable to comply with the study procedures and assessments.