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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05522387




Registration number
NCT05522387
Ethics application status
Date submitted
18/08/2022
Date registered
31/08/2022

Titles & IDs
Public title
An Open-Label Extension of XPro1595 in Patients With Alzheimer's Disease
Scientific title
An Open Label Extension of XPro1595 in Patients With Alzheimer's Disease That Have Completed a Phase 1 or Phase 2 Study With XPro1595
Secondary ID [1] 0 0
XPro1595-AD-OLE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Dementia 0 0
Brain Diseases 0 0
Central Nervous System Diseases 0 0
Nervous System Diseases 0 0
Tauopathies 0 0
Neurodegenerative Diseases 0 0
Neurocognitive Disorders 0 0
Mental Disorders 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Neurodegenerative diseases
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XPro1595

Experimental: Experimental: 1.0 mg/kg XPro1595 - Patients will receive XPro1595.


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants who experience adverse events and serious adverse events
Timepoint [1] 0 0
Weeks 55, or 74 in the OLE Study
Secondary outcome [1] 0 0
To evaluate the change in cognitive performance following administration of open-label XPro1595
Timepoint [1] 0 0
Week 55 in the OLE Study
Secondary outcome [2] 0 0
To evaluate the change in cognition and global function following administration of open-label XPro1595
Timepoint [2] 0 0
Week 55 in the OLE Study
Secondary outcome [3] 0 0
To evaluate the change in non-cognitive behavioral symptoms following open-label administration of XPro1595
Timepoint [3] 0 0
Week 55 in the OLE Study
Secondary outcome [4] 0 0
To evaluate the change Change from Baseline on the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS- MCI- ADL)
Timepoint [4] 0 0
Week 55 in the OLE Study
Secondary outcome [5] 0 0
To evaluate the change on blood inflammatory and neurodegeneration biomarkers following open-label administration of XPro1595 (on blood inflammatory and neurodegeneration biomarker amyloid)
Timepoint [5] 0 0
Weeks 55, or 74 in the OLE Study
Secondary outcome [6] 0 0
To evaluate the change on blood inflammatory and neurodegeneration biomarkers following open-label administration of XPro1595 (on blood inflammatory and neurodegeneration biomarker pTau)
Timepoint [6] 0 0
Weeks 55, or 74 in the OLE Study
Secondary outcome [7] 0 0
To evaluate the change on imaging neuroinflammation following open-label administration of XPro1595
Timepoint [7] 0 0
Weeks 55, or 74 in the OLE Study
Secondary outcome [8] 0 0
To evaluate the change on axonal integrity following open-label administration of XPro1595
Timepoint [8] 0 0
Weeks 55, or 74 in the OLE Study
Secondary outcome [9] 0 0
To evaluate the change in Everyday Cognition (ECog) following open-label administration of XPro1595
Timepoint [9] 0 0
Week 55 in the OLE Study

Eligibility
Key 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.
Minimum age
55 Years
Maximum age
86 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
KaRa MINDS - Macquarie Park
Recruitment hospital [2] 0 0
Neuro Trials Victoria Pty Ltd T/A NeuroCentrix - Carlton
Recruitment hospital [3] 0 0
Austin Health - Ivanhoe
Recruitment hospital [4] 0 0
Australian Alzheimer's Research Foundation - Perth
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 0 0
3079 - Ivanhoe
Recruitment postcode(s) [4] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Inmune Bio, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tara Lehner
Address 0 0
INmune Bio
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05522387