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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03943264




Registration number
NCT03943264
Ethics application status
Date submitted
26/04/2019
Date registered
9/05/2019

Titles & IDs
Public title
A Biomarker-directed Study of XPro1595 in Patients With Alzheimer's
Scientific title
Phase 1b Open-Label, Dose-Identification Study of XPro1595 in Patients With Alzheimer's Disease and Biomarkers of Inflammation.
Secondary ID [1] 0 0
18PTC-R-592167
Secondary ID [2] 0 0
XPRO1595-AD
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

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

Experimental: 0.3 mg/kg XPro1595 - 0.3 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 12 weeks.

Experimental: 0.6 mg/kg XPro1595 - 0.6 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 12 weeks.

Experimental: 1.0 mg/kg XPro1595 - 1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 12 weeks.


Treatment: Drugs: XPro1595
XPro1595 will be delivered by subcutaneous injection once a week
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of patients with a treatment-emergent adverse event throughout 12 weeks of treatment with XPro1595
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
The percentage of patients with a treatment-emergent adverse event throughout 12 weeks of treatment with XPro1595
Timepoint [2] 0 0
12 weeks
Secondary outcome [1] 0 0
Changes from baseline in high sensitivity C-reactive protein in the blood and cerebral spinal fluid following 12 weeks of treatment with XPro1595
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Changes from baseline in inflammatory cytokines in the blood and cerebral following 12 weeks of treatment with XPro1595 spinal fluid
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Changes from baseline in blood and cerebral spinal fluid levels of amyloid beta following 12 weeks of treatment with XPro1595
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Changes from baseline in cerebral spinal fluid levels of tau following 12 weeks of treatment with XPro1595
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Change from baseline in FreeWater content (edema) using magnetic resonance imaging following 12 weeks of treatment with XPro1595
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Change from baseline in the Mini-Mental State Examination (MMSE) following 12 weeks of treatment with XPro1595
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Change from baseline in the Digit Symbol Substitution Test (DSST) following 12 weeks of treatment with XPro1595
Timepoint [7] 0 0
12 weeks
Secondary outcome [8] 0 0
Change from baseline in the Verbal Fluency Test following 12 weeks of treatment with XPro1595
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
Change from baseline in the Neuropsychiatric Inventory (NPI) following 12 weeks of treatment with XPro1595
Timepoint [9] 0 0
12 weeks
Secondary outcome [10] 0 0
Change from baseline in the Bristol Activities of Daily Living Scale (BALDS) following 12 weeks of treatment with XPro1595
Timepoint [10] 0 0
12 weeks
Secondary outcome [11] 0 0
Change from baseline in the Memory-Enhanced Retrospective Evaluation of Treatment Observer Reported Global Impression of Improvement (MERET OBSRO-C) following 12 weeks of treatment with XPro1595
Timepoint [11] 0 0
12 weeks
Secondary outcome [12] 0 0
Evaluate changes in the Memory-Enhanced Retrospective Evaluation of Change from baseline Global Impression of Improvement (MERET PGI-C) following 12 weeks of treatment with XPro1595
Timepoint [12] 0 0
12 weeks

Eligibility
Key inclusion criteria
1. Aged 18 years and above at screening;
2. Diagnosed with probable AD defined by the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria;
3. Has hsCRP levels =1.5mg/L,OR HbA1c = 6DCCT %, OR Erythrocyte Sedimentation Rate (ESR) =10 mm/h, OR APOE4 positive (at least one APOE4 allele);
4. Female of childbearing potential (FCBP) must have confirmed negative urine pregnancy test at Screening;
5. All female of childbearing potential (FCBP) and male patients who are sexually active with a female of childbearing potential must agree to use a highly effective contraception during the treatment period and until 90 days after the last dose of treatment for sexually active males whose partners are FCBP or until 30 days after the last dose of treatment for FCBP.
6. Consents to having lumbar punctures;
7. Consents to apolipoprotein E (APOE) genotyping(if status unknown);
8. Provide written informed consent prior to any study procedures being performed;
9. Has a caregiver who either lives in the same household or interacts withthe patient at least 4 hours per day and at least 4 days per week, who is knowledgeable about the participant's daytime and night-time behaviours and who canbe available to attend all clinic visits in personat which caregiver assessments are performed.Patients with caregivers that do not meet this criterionbut are determined by the investigator as able to provide an adequate assessment of the patient may also participate with prior approval from the sponsor.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients taking cholinesterase inhibitors, memantine, or antidepressant medication for less than 45 days from Day 1 (i.e. must be on stable dose for at least 45 days prior to Day 1);
2. Have taken within the last 45 days from Day 1; corticosteroids or other immunosuppressive drugs, thalidomide or other TNF active drugs, minocycline.
3. Enrolled in another clinical trial where patients receive treatment with investigational drug or device or have received treatment on another AD clinical trial within the last 60 days from Day 1;
4. Unable to tolerate lumbar puncture or taking medicine where lumber punctures are contraindicated (anti-coagulants besides daily 100mg of aspirin);
5. A prior organ or stem cell transplant;
6. A major adverse cardiac event within 6 months before screening;
7. Lymphoma, leukaemia, or any malignancy within the past 5 years with the exception of malignancies with negligible risk of metastasis or death, such as basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ that have been resected with no evidence of metastatic disease for 3 years;
8. Jaundice, active hepatitis, or known hepatobiliary disease (except asymptomatic cholelithiasis);
9. Positive screening assessment for viral hepatitis B surface antigen or hepatitis C virus (HCV) antibody and positive HCV ribonucleic acid or human immunodeficiency virus, or a history of illicit drug injecting;
10. Seated blood pressure of = 165/105 mmHg at screening;
11. Unable to comply with the study procedures and assessments;12.Known hypersensitivity to investigational product or its excipients;

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2021
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
KaRa MINDS - Macquarie Park
Recruitment hospital [2] 0 0
Mater Medical Research Institute - Brisbane
Recruitment hospital [3] 0 0
Central Adelaide Local Health Network - Woodville
Recruitment hospital [4] 0 0
Alfred Heath - Melbourne
Recruitment hospital [5] 0 0
Eastern Clinical Research Unit - Melbourne
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [2] 0 0
4101 - Brisbane
Recruitment postcode(s) [3] 0 0
5011 - Woodville
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3128 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Inmune Bio, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Alzheimer's Association
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Terrence O'Brien, MD
Address 0 0
The Alfred
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)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT03943264