Actively Recruiting
Study of Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of NIO752 in Early Alzheimer's Disease Participants
Led by Novartis Pharmaceuticals · Updated on 2025-08-28
36
Participants Needed
10
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase 1b study to assess the pharmacodynamics, safety, tolerability, and pharmacokinetics of NIO752 in patients with early Alzheimer's disease (AD)
CONDITIONS
Official Title
Study of Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of NIO752 in Early Alzheimer's Disease Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 30 to 74 years old at the time of informed consent
- Diagnosed with mild Alzheimer's Disease or mild cognitive impairment due to Alzheimer's disease with documented cognitive decline for at least 6 months
- Clinical Dementia Rating Scale Global Score of 0.5 or 1 and a Memory Score 0.5 at screening
- Historical cerebrospinal fluid biomarkers confirming Alzheimer's disease diagnosis, or positive amyloid and tau biomarker results from screening lumbar puncture if no prior data (for cohorts 1 & 2)
- Has a reliable study partner or caregiver aged 18 or older
- Lives close enough to the study site to allow timely visits if needed
- Able to undergo lumbar puncture, cerebrospinal fluid collection, blood draws, brain MRI, PET scans, and tolerate study procedures
- For open-label extension (OLE), signed informed consent for OLE and completed Day 170 of placebo-controlled part
You will not qualify if you...
- Lives in a skilled nursing or dementia care facility
- Used experimental therapy within 180 days or 5 half-lives before Day 1; no prior use of amyloid or tau vaccines, oligonucleotides, or gene therapy allowed
- Has current or past neurological conditions other than Alzheimer's disease
- Has medical conditions like poorly controlled diabetes, unstable angina, myocardial infarction, heart failure, conduction abnormalities, or impaired kidney function that make participation unsuitable
- Currently taking immunosuppressants, antipsychotics, lithium, neuroleptics, dopaminergic agonists, L-dopa, or monoamine oxidase inhibitors; stable cholinesterase inhibitors/memantine allowed
- Brain MRI showing cerebrovascular disease or other imaging abnormalities making participation unsuitable
- For OLE, use of investigational drugs other than NIO752 or withdrew consent during placebo-controlled part
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Novartis Investigative Site
Kuopio, Finland, 70210
Completed
2
Novartis Investigative Site
Turku, Finland, 20520
Completed
3
Novartis Investigative Site
Lille, France, 59037
Actively Recruiting
4
Novartis Investigative Site
Paris, France, 75013
Actively Recruiting
5
Novartis Investigative Site
Toulouse, France, 31059
Actively Recruiting
6
Novartis Investigative Site
Valencia, Valencia, Spain, 46017
Actively Recruiting
7
Novartis Investigative Site
Barcelona, Spain, 08036
Actively Recruiting
8
Novartis Investigative Site
Barcelona, Spain, 08041
Actively Recruiting
9
Novartis Investigative Site
Malmö, Sweden, 221 85
Completed
10
Novartis Investigative Site
Stockholm, Sweden, 141 86
Completed
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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