Brief Summary

The goal of this Phase 2 Alzheimer's study is to determine whether 1.0 mg/kg XPro1595 confers a benefit on cognition, function, and biomarkers of white matter and to further evaluate safety and tolerability. The objectives of this study are to determine the safety, tolerability, and efficacy of XPro1595 in patients with early ADi.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

208

participants targeted

Target at P75+ for phase_2 alzheimer-disease

Timeline

Completed

Started Feb 2022

Typical duration for phase_2 alzheimer-disease

Geographic Reach

8 countries

41 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.2 years study duration

Study Start

First participant enrolled

February 28, 2022

Completed

7 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed

1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2025

Completed

Last Updated

March 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.2 years

First QC Date

March 7, 2022

Last Update Submit

March 23, 2026

Conditions

Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Mild Cognitive Impairment

Keywords

InflammationBiomarkerTNF

Outcome Measures

Primary Outcomes (1)

Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)
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 (Word List learning Test) * Digit Span Forward and Backward * Category Fluency Test (DKEFS) * Letter Fluency Test (DKEFS) * Trail Making Test Parts A and B * Digit Symbol Coding Test To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with early ADi
24 Weeks

Secondary Outcomes (11)

Change in Clinical Dementia Rating (CDR)
24 Weeks
Change in apparent fiber density (AFD)
24 Weeks
Change in Everyday Cognition (E-Cog)
24 Weeks
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-MCI-ADL)
24 Weeks
Change in myelin content
24 Weeks
+6 more secondary outcomes

Other Outcomes (1)

Change in Goal Attainment Scale (GAS)
24 Weeks

Study Arms (2)

1.0 mg/kg XPro1595

EXPERIMENTAL

1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks.

Drug: XPro1595

1.0 mg/kg Placebo

PLACEBO COMPARATOR

1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks.

Drug: Placebo

Interventions

XPro1595DRUG

XPro1595 will be delivered by subcutaneous injection once a week

Also known as: INB03/XPro™, XENP1595, DN-TNF

1.0 mg/kg XPro1595

PlaceboDRUG

Placebo will be delivered by subcutaneous injection once a week

Also known as: Matching Placebo

1.0 mg/kg Placebo

Eligibility Criteria

Age50 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

To be eligible for study entry, patients must satisfy all of the following criteria:
Adult patients 50 years to ≤ 85 years of age at the time of consent;
Meets the diagnostic criteria of 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);
Amyloid positive (documented in medical history or assessed during screening through blood test);
Either currently or previously (in pre-AD condition) literate and capable of reading, writing, and communicating effectively with others;
Residence in an assisted living is allowed as is personal assistances provided in the home, however at time of enrollment participant must be able to perform most ADL with minimal assistance, and participant must be permitted sufficient independence to allow assessment of change in ADL;
Has a study partner 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 caregiver assessments are performed.

You may not qualify if:

Patients will be excluded from the study if 1 or more of the following criteria are applicable:
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);
Receives considerable help to carry out basic ADL living either in the home or as a resident in a nursing home or similar facility;
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 suicidality.
History of substance abuse within 12 months; use of cannabis or cannabis products within 6 months of consent;
Enrolled in another clinical trial where patients receive treatment with an investigational drug or treatment device or have had previous treatment with any investigational medicinal product within 60 days or 5 half-lives (whichever is longer) prior to study drug treatment;
A prior organ or stem cell transplant;
Seated blood pressure of ≥ 165/105 mmHg at Screening.

Contact the study team to confirm eligibility.