A Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients with Early Alzheimer’s Disease with Biomarkers of Inflammation

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Inmune Bio Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

1 Mar 2024 → 5 May 2025

Decision date (initial)

2024-04-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

INmune Bio, Inc.

External identifiers

EU CT number

2023-505396-71-00

ClinicalTrials.gov

NCT05318976

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with early ADi

Secondary objectives 3

1. To assess the effect of XPro1595 compared with placebo on cognition and global function in patients with early ADi
2. To evaluate the effect of XPro1595 compared with placebo on E-Cog in patients with early ADi
3. To assess the effect of XPro1595 compared with placebo on noncognitive behavioral symptoms in patients with early ADi

Conditions and MedDRA coding

Early Alzheimer’s Disease with Biomarkers of Inflammation

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Adult patients 50 years to ≤ 85 years of age at the time of consent 2. Diagnosed with MCI of probable Alzheimer’s disease (Jack et al. 2018; NIA-AA) or mild dementia as clinically described in McKhann, (2011) and corresponding to stages 3 or 4 of the revised AD staging system (Jack, 2018). (NIA - AA); 3. CDR global rating at screening of 0.5 or 1 4. MMSE > 22; 5. ECog memory subscale items mean > 1.5 6. Presence of at least 1 inflammatory biomarker: • hsCRP > 1.5 mg/L • ESR > 10 mm/h • HbA1C > 6 DCCT % • At least 1 APOE4 allele

Exclusion criteria 1

1. 1. Have any contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (e.g., in-skull and cardiac devices other than those approved as safe for use in MRI scanners). 2. Have any evidence of other clinically significant lesion(s) that could confound or indicate a dementia diagnosis other than AD on brain CT and/or MRI at Screening. 3. Receives considerable help to carry out basic ADL living either in the home or as a resident in a nursing home or similar facility. 4. Lifetime history of a major psychiatric disorder including schizophrenia and bipolar disorder. Major depressive disorder that has resulted in 2 or more hospitalizations in a lifetime. Major depressive episode during the past 5 years that is judged by the clinical team unlikely to have been part of Alzheimer’s prodrome. History of suicidal behavior, or answer of ‘yes” to C-SSRS suicidal ideation items 4 or 5 within 12 months of screening. 5. History of substance abuse within 12 months; use of cannabis or cannabis products within 6months of consent. 6. Have taken within the last 90 days from Day 1: corticosteroids or other immunosuppressive drugs, thalidomide or other TNF active drugs, minocycline, first- or second-generation antipsychotics (e.g., aripripozole) or aducanumab.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in the Early and Mild Alzheimer’s Cognitive Composite (EMACC) from Baseline to Week 24 in the following assessments: International Shopping List Test-Immediate Recall Digit Span Forward and Backward Category Fluency Test (DKEFS) Letter Fluency Test (DKEFS) Trail Making Test Parts A and B Digit Symbol Coding Test

Secondary endpoints 1

1. Change from Baseline to Week 24 in Clinical Dementia Rating Scale (CDR) Change from Baseline to Week 24 in Everyday Cognition (E-Cog) Change from Baseline to Week 24 in (Neuropsychiatric Inventory [NPI-12] caregiver items)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Inmune Bio Inc.

Sponsor organisation

Inmune Bio Inc.

Address

225 Northeast Mizner Boulevard Suite 640

City

Boca Raton

Postcode

33432-4080

Country

United States

Scientific contact point

Organisation

Inmune Bio Inc.

Contact name

Head of Neuroscience

Public contact point

Organisation

Inmune Bio Inc.

Contact name

Head of Neuroscience

Locations

6 EU/EEA countries · 47 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 129 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications