At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- DNL628 (drug), Placebo (drug)
- How long the study runs
- Study runs about 13 months (dates as stated)
- About the drug or intervention
- DNL628 — drug: Multiple ascending doses · Placebo — drug: Multiple ascending doses
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Denali Therapeutics Inc., is looking at a medicine called DNL628 in people with early Alzheimer's disease (a condition affecting memory and thinking). The researchers want to find out how safe the medicine is, how well people cope with it, and how it moves through and acts in the body.
Who can take part
- Have a body mass index (BMI, a measure of weight for height) of 18 to under 32 and weigh at least 45 kg
- Have a diagnosis of probable Alzheimer's disease dementia, based on set medical criteria
- Have evidence of Alzheimer's-related changes in the brain (amyloid positivity), shown by past records or tests
- Be at an early stage: a Clinical Dementia Rating (a memory and thinking score) of 0.5 or 1, and a Mini-Mental State Examination (a short memory and thinking test) score of 20 to 30
Who may not be able to
- Have other significant brain, nerve, or thinking disorders besides Alzheimer's disease
- Have significant mental health conditions
- Have unstable or poorly controlled medical conditions (such as heart, lung, liver, hormone, or gut problems) that could affect taking part
- Have had cancer in the past 5 years, apart from some low-risk or fully removed cancers
- Have had previous anti-amyloid or anti-tau treatment, including vaccines (with a possible exception for some people who had certain treatment more than 6 months ago, if agreed by the study team)
- Have had gene therapy before
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 68
- Started
- 2026-01-30
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for alzheimer disease, early onset
- • Phase1 - 68 participants
- • This is a Phase 1b, multicenter, randomized, placebo-controlled, double-blind, multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL628 in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment, or mild AD with biomarker evidence of amyloid positivity
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with alzheimer disease, early onset
Where?
- • London - Clinical Site(s)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a Phase 1b, multicenter, randomized, placebo-controlled, double-blind, multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL628 in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment, or mild AD with biomarker evidence of amyloid positivity. Note: In the Netherlands, this study includes an open-label extension.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓BMI of ≥18 to \< 32 kg/m2 and body weight of ≥45 kg
- ✓Have a diagnosis of probable AD dementia based on NIA AA 2011 criteria, including amnestic or nonamnestic...
- ✓Have supportive evidence of AD pathology via historical records or laboratory testing at screening for amyloid...
- ✓Have AD severity defined as the following at screening:
- ✓A Clinical Dementia Rating global score of 0.5 or 1
Who cannot take part
- ✗Have clinically significant neurological or cognitive disorders affecting the CNS other than AD, as determined by...
- ✗Have clinically significant psychiatric conditions
- ✗Have had previous anti amyloid or anti tau treatment that helps your immune system fight cancer (including active immunization)
- ✗Note: ADAD participants who have participated in previous passive anti-amyloid treatment that helps your immune system fight cancer \> 6 months previously...
- ✗Have had previous exposure to gene therapy
See the full criteria
Where Is This Study? (1 UK site)
Clinical Site(s)
London, United Kingdom
How to Get in Touch
Clinical Trials at Denali Therapeutics
Sponsor contactCONTACT
