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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05469360
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • NIO752 — DRUG
    A single intrathecal (cerebrospinal) injection of NIO752 of Dose A
  • NIO752 — DRUG
    A single intrathecal (cerebrospinal) injection of NIO752 at dose B
  • Matching placebo — DRUG
    A single intrathecal injection of matching placebo
  • NIO752 — DRUG
    Multiple intrathecal injections of NIO752 of Dose A
  • NIO752 — DRUG
    Two intrathecal injections of NIO752 at dose C
  • NIO752 — DRUG
    Single intrathecal injection of NIO752 at dose C
  • Matching placebo — DRUG
    Two intrathecal injections of matching placebo

Study Details

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

Key Dates

First listed
Jul 21, 2022
Start date
Feb 23, 2023
Status verified
May 2026
Primary completion
Jul 30, 2026
Completion
Sep 24, 2027

Study Design

Enrollment
38 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: NIO752 - Dose A - Cohort 1
    A single intrathecal injection of Dose A
  • Placebo Comparator: Matching placebo - Cohort 1
    A single intrathecal injection of artificial cerebrospinal fluid (CSF)
  • Experimental: NIO752 Dose B - Cohort 2
    A single intrathecal injection of Dose B
  • Placebo Comparator: Matching placebo - Cohort 2
    A single intrathecal injection of artificial cerebrospinal fluid (CSF)
  • Experimental: NIO752 OLE - Cohorts 1 and 2
    Multiple intrathecal injections of Dose A
  • Experimental: NIO752 - Dose C - Cohort 3
    Two intrathecal injections of Dose C
  • Placebo Comparator: Matching Placebo - Cohort 3
    Two intrathecal injections of artificial cerebrospinal fluid (CSF)
  • Experimental: NIO752 OLE - Cohort 3
    Single intrathecal injection of Dose C

Primary Outcome Measure

Change in cerebrospinal total tau from baseline to Day 85 [ Time Frame: Baseline, Day 85 ]

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