Actively Recruiting
A Trial Evaluating the Effect of NIO752 on Tau Synthesis Measured by a Process Known as SILK
Led by University College, London · Updated on 2026-01-27
10
Participants Needed
2
Research Sites
84 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
W
Washington University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will assess if drug (NIO752) reduces production of a protein, tau, by the brain. Normally tau maintains the internal skeleton of nerve cells. In Alzheimer's disease (AD) it builds up in the brain, causing damage. Abnormal tau proteins cling to each other forming 'tangles' inside nerve cells, which interfere with how the nerve cells work, and eventually die. This is what causes the symptoms of dementia. It is thought that NIO752 reduces production of tau.
CONDITIONS
Official Title
A Trial Evaluating the Effect of NIO752 on Tau Synthesis Measured by a Process Known as SILK
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent.
- Between 21 to 80 years old (inclusive).
- Diagnosed with mild or moderate Alzheimer's disease with a Clinical Dementia Rating score from 0.5 to 2, and able to complete the study.
- History of cerebrospinal fluid, PET, or blood biomarkers supporting Alzheimer's diagnosis, or confirmed presenilin or amyloid precursor protein mutation carriers.
- Fluent in English.
- Has a reliable study partner or caregiver.
- Able to undergo lumbar punctures, MRI, cerebrospinal fluid draws, and blood draws.
- Willing to consent to sharing biological samples and personal data with the commercial partner (Novartis).
You will not qualify if you...
- Lives in a skilled nursing or dementia care facility.
- Has any significant laboratory abnormalities.
- Attempted suicide or had suicidal ideation requiring hospital admission within 12 months before screening.
- Used any experimental therapy within 180 days or 5 half-lives before Day 1, whichever is longer.
- Previously used MAPT antisense oligonucleotides or other gene therapies for Alzheimer's.
- History of hypersensitivity to study treatments or similar drugs.
- Has conditions increasing meningitis risk without proper prophylactic treatment.
- Has medical or neurological conditions affecting cognition or cognitive tests.
- Has other conditions making participation unsuitable or interfering with study completion per investigator judgment.
- Unlikely to cooperate, attend visits, or follow instructions per investigator judgment.
- Current alcohol intake over 14 units per week, current cannabis use, or history of substance abuse (except nicotine) within 2 years before screening.
- Currently treated with immunosuppressants, antipsychotics, lithium, neuroleptics, dopaminergic agonists, L-dopa, or monoamine oxidase inhibitors; stable doses of cholinesterase inhibitors or memantine allowed.
- Unable to undergo MRI due to claustrophobia or contraindications like metallic implants or pacemakers.
- Shows significant signs of major cerebrovascular disease.
- Sexually active males must agree to use condoms from consent until 15 weeks after treatment.
- Breastfeeding or pregnant women, or females of reproductive potential not using highly effective contraception.
- On regular anticoagulants or anti-platelets that prevent lumbar puncture.
- Seropositive for HIV, Hepatitis B, or Hepatitis C.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
2
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Actively Recruiting
Research Team
R
Ross Paterson
CONTACT
L
Lisa French
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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