RecruitingPhase 1NCT05469360

Study of Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of NIO752 in Early Alzheimer's Disease Participants

A Randomized, Participant and Investigator Blinded, Placebo-Controlled Study to Evaluate the Ability of a Single Intrathecally Administered Dose of NIO752 to Lower Cerebrospinal Fluid Total Tau Levels in Participants With Early Alzheimer's Disease


Sponsor

Novartis Pharmaceuticals

Enrollment

36 participants

Start Date

Feb 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Phase 1b study to assess the pharmacodynamics, safety, tolerability, and pharmacokinetics of NIO752 in patients with early Alzheimer's disease (AD)


Eligibility

Min Age: 30 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing the safety, how the body processes, and the early effects of a new experimental drug in patients with advanced solid tumors (cancers that form lumps in organs or tissues). **You may be eligible if...** - You have an advanced solid tumor cancer that has not responded to standard treatments - You are in generally good health aside from your cancer (able to carry out daily activities) - You have measurable disease on imaging scans - You have adequate organ function (liver, kidneys, blood counts) **You may NOT be eligible if...** - You have had recent major surgery or radiation - You have a serious active infection - You have uncontrolled brain metastases (cancer spread to the brain) - You are pregnant or breastfeeding - You have severe heart, liver, or kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNIO752

A single intrathecal (cerebrospinal) injection of NIO752 of Dose A

DRUGNIO752

A single intrathecal (cerebrospinal) injection of NIO752 at dose B

DRUGMatching placebo

A single intrathecal injection of matching placebo

DRUGNIO752

Multiple intrathecal injections of NIO752 of Dose A

DRUGNIO752

Two intrathecal injections of NIO752 at dose C

DRUGNIO752

Single intrathecal injection of NIO752 at dose C

DRUGMatching placebo

Two intrathecal injections of matching placebo


Locations(10)

Novartis Investigative Site

Kuopio, Finland

Novartis Investigative Site

Turku, Finland

Novartis Investigative Site

Lille, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Toulouse, France

Novartis Investigative Site

Valencia, Valencia, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Malmö, Sweden

Novartis Investigative Site

Stockholm, Sweden

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NCT05469360


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