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

NCT05469360 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-08-28

No results posted yet for this study

Summary

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

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Madhav Thambisetty, MD PhD · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-23
Primary Completion
2026-09-11
Completion
2028-01-02

Countries

  • Finland
  • France
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT05469360 on ClinicalTrials.gov