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Evaluating the Efficacy and Safety of Nilotinib BE in Subjects With Early Alzheimer's Disease

NCT05143528 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1275

Last updated 2021-12-03

No results posted yet for this study

Summary

This study will investigate the safety and efficacy of a Tyrosine Kinase Inhibitor (TKI) called Nilotinib BE (bioequivalent) in individuals with Early Alzheimer's disease (EAD). This is a multi-center double blinded, Phase 3 study, that will enroll patients for three years in approximately 50 centers nationwide. The total duration of the study will be for five years.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Nilotinib BE 84mg

84 mg capsule

DRUG

Nilotinib BE 112 mg

112 mg capsule

DRUG

Placebo

placebo capsule

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Life Molecular Imaging GmbH

    collaborator INDUSTRY

  • Sun Pharmaceuticals Industries Limited

    collaborator UNKNOWN

  • KeifeRx, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2025-12-31
Completion
2026-06-01
FDA Drug
Yes

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05143528 on ClinicalTrials.gov