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Trial Title:
An Open-Label Extension of XPro1595 in Patients With Alzheimer's Disease
NCT ID:
NCT05522387
Condition:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Conditions: Official terms:
Alzheimer Disease
Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
Tauopathies
Mental Disorders
Neurocognitive Disorders
Conditions: Keywords:
Inflammation
Biomarker
Tumor Necrosis Factor (TNF)
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
An Open-Label Extension of XPro1595 in Patients with Alzheimer's Disease (AD) That Have
Completed a Phase 2 Study with XPro1595
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
XPro1595
Description:
Each enrolled patient will be treated with 1.0 mg/kg of XPro1595 as a subcutaneous
injection once a week for 55, or 74 weeks, for a total exposure to XPro1595 of up to 78
weeks (18 months), depending on their previous study.
Arm group label:
Experimental: 1.0 mg/kg XPro1595
Other name:
INB03/XPro™
Other name:
XENP1595
Other name:
DN-TNF
Summary:
The goal of this Phase 2 Open Label study is to evaluate long-term safety, tolerability,
and efficacy of XPro1595 on measures of cognition, function and brain quality in
individuals with Alzheimer's Disease.
Detailed description:
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 (AD). The
planned dose is 1.0 mg/kg of XPro1595 for all subjects that completed a previous Phase 1
or Phase 2 study with XPro1595.
Each enrolled patient will be treated with 1.0 mg/kg of XPro1595 as a subcutaneous
injection once a week for 55 or 74 weeks, for a total exposure to XPro1595 of up to 78
weeks (18 months), depending on their previous study. Blood sampling for clinical lab
analyses, physical exam findings, ECG and C-SSRS will be collected throughout the study
to assess the safety and tolerability of XPro1595. Imaging endpoints (MRI), blood
sampling for neuroinflammatory and neurodegenerative biomarkers, clinical ratings
(CDR-SB, ADCS-MCI ADL, NPI-12) and cognitive performance assessed via the EMACC will be
collected at screening and at Weeks 12, 24, 36, and 48. Depending on the parent study,
some or all of these assessments may also be made at Weeks 55, 60 or 74.
All patients that completed 4 weeks of dosing and the week 5 PK draw in the Phase 1 PK
Lead-In or completed the treatment period and End of Study (EOS) assessments in a Phase 2
study are eligible to enroll into the OLE study. All patients enrolled, including those
treated with placebo in the parent study, will receive 1.0 mg/kg XPro1595. Randomized
treatment will remain blinded until the parent study database is locked, the study is
unblinded and results for their prior study are released.
Criteria for eligibility:
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 study.
2. Concomitant medications for the management of 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 (However, this is not a requirement for patients
coming from the AD-02 PK Lead-In Study).
5. All male subjects who are sexually active with a female of childbearing potential
(FCBP) must agree to use a highly effective method of contraception during the
treatment period and until 90 days after the last dose of treatment.
6. 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.
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.
Gender:
All
Minimum age:
55 Years
Maximum age:
86 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
KaRa MINDS
Address:
City:
Macquarie Park
Zip:
2113
Country:
Australia
Facility:
Name:
Neuro Trials Victoria Pty Ltd T/A NeuroCentrix
Address:
City:
Carlton
Zip:
3053
Country:
Australia
Facility:
Name:
Austin Health
Address:
City:
Ivanhoe
Zip:
3079
Country:
Australia
Facility:
Name:
Australian Alzheimer's Research Foundation
Address:
City:
Perth
Zip:
6009
Country:
Australia
Start date:
February 21, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Inmune Bio, Inc.
Agency class:
Industry
Source:
Inmune Bio, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05522387
https://www.alz.org/alzheimers-dementia/facts-figures