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RECRUITING
NCT05469360
PHASE1

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

30 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2023-02-23

Completion Date

2028-01-02

Last Updated

2025-08-28

Healthy Volunteers

No

Interventions

DRUG

NIO752

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

DRUG

NIO752

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

DRUG

Matching placebo

A single intrathecal injection of matching placebo

DRUG

NIO752

Multiple intrathecal injections of NIO752 of Dose A

DRUG

NIO752

Two intrathecal injections of NIO752 at dose C

DRUG

NIO752

Single intrathecal injection of NIO752 at dose C

DRUG

Matching 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

Malmo, Sweden

Novartis Investigative Site

Stockholm, Sweden