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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
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.
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)
Secondary study objectives
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-MCI-ADL)
Change in Clinical Dementia Rating (CDR)
Change in Everyday Cognition (E-Cog)
+8 moreOther study objectives
Change in Goal Attainment Scale (GAS)
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
Find a Location
Who is running the clinical trial?
Inmune Bio, Inc.Lead Sponsor
6 Previous Clinical Trials
142 Total Patients Enrolled
Patricia HopkinsStudy DirectorINmune Bio
2 Previous Clinical Trials
11 Total Patients Enrolled
Therese BlombergStudy DirectorINmune Bio
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can read, write, and communicate effectively.I need a lot of help with daily activities like eating, dressing, and bathing.I am between 50 and 85 years old.I have been diagnosed with early Alzheimer's disease.I have not had major psychiatric disorders, multiple hospitalizations for depression, recent severe depression, a history of suicidal thoughts, or substance abuse in the last year.I can do most daily activities by myself, even if I live in assisted living or have help at home.I have someone who can be with me for my trial visits and knows about my daily habits.I have had an organ or stem cell transplant.I have been diagnosed with mild dementia.
Research Study Groups:
This trial has the following groups:- Group 1: 1.0 mg/kg XPro1595
- Group 2: 1.0 mg/kg Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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