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XPro1595 for Alzheimer's Disease (MINDFuL Trial)

Phase 2

Recruiting

Research Sponsored by Inmune Bio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 28 days post last dose

Awards & highlights

MINDFuL Trial Summary

This trial looks at how a new medicine affects memory and biology in people with mild Alzheimer's Disease.

Who is the study for?

This trial is for adults aged 60-85 with mild Alzheimer's Disease, confirmed by a biomarker test. Participants must be able to perform daily activities with minimal help and have a caregiver available. Those in other trials, with severe blood pressure issues, MRI contraindications, major psychiatric disorders or recent substance abuse are excluded.Check my eligibility

What is being tested?

The study tests XPro1595 against a placebo in patients with mild Alzheimer's Disease. It aims to assess the drug's impact on cognitive functions and biological markers of inflammation when given as an injection under the skin.See study design

What are the potential side effects?

Potential side effects of XPro1595 may include reactions at the injection site, general inflammation responses due to immune system modulation, and any common adverse effects associated with subcutaneous injections.

MINDFuL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 28 days post last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 28 days post last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 28 days post last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)

Secondary outcome measures

Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

Change in Clinical Dementia Rating (CDR)

Change in Everyday Cognition (E-Cog)

+8 more

Other outcome measures

Change in Goal Attainment Scale (GAS)

MINDFuL Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 1.0 mg/kg XPro1595Experimental Treatment1 Intervention

1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks.

Group II: 1.0 mg/kg PlaceboPlacebo Group1 Intervention

1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

XPro1595

2019

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Inmune Bio, Inc.Lead Sponsor

6 Previous Clinical Trials

399 Total Patients Enrolled

2 Trials studying Brain Diseases

261 Patients Enrolled for Brain Diseases

Patricia HopkinsStudy DirectorINmune Bio

2 Previous Clinical Trials

261 Total Patients Enrolled

2 Trials studying Brain Diseases

261 Patients Enrolled for Brain Diseases

Therese BlombergStudy DirectorINmune Bio

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05318976 — Phase 2

Brain Diseases Research Study Groups: 1.0 mg/kg XPro1595, 1.0 mg/kg Placebo

Brain Diseases Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05318976 — Phase 2

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05318976 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research program accept participants below the age of 45?

"According to the eligibility criteria, only individuals aged between 60 and 85 can apply for this trial. There are 452 trials available for minors and 1,944 studies open to seniors over 65 years of age."

Answered by AI

Am I eligible to participate in the research endeavor?

"To be eligible for this clinical trial, the participant must have a central nervous system disorder and must fall within an age range of 60 to 85 years old. The study is hoping to recruit approximately 201 individuals."

Answered by AI

What adverse effects have been linked to a 1.0 mg/kg dosage of XPro1595?

"On a scale of one to three, our team at Power assessed the safety of 1.0 mg/kg XPro1595 as 2 due to lack of efficacy data from Phase 2 trials yet evidence for safety being present."

Answered by AI

Are there still open spots for participation in this trial?

"Affirmative. Clinicaltrials.gov indicates that the study, which was initially published on February 28th 2022, is actively recruiting individuals to participate. A total of 201 participants are needed for this trial between 2 sites."

Answered by AI

How many participants are accepted into this medical trial?

"Indeed, the clinicaltrials.gov website reveals that this experiment is presently enrolling participants. Originally posted on February 28th 2022, it has seen its most recent update on February 16th 2023 and seeks to recruit 201 patients from two separate sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation

2022. "A Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05318976.

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