Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease

Sponsor: Denali Therapeutics Inc.

NCT ID: NCT07328451

View on ClinicalTrials.gov ↗

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.

Alzheimer Disease, Early Onset

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Key Inclusion Criteria: * 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 presentation at screening * Have supportive evidence of AD pathology via historical records or laboratory testing at screening for amyloid positivity * Have AD severity defined as the following at screening: * A Clinical Dementia Rating global score of 0.5 or 1 * A Mini-Mental State Examination score of 20 to 30 (inclusive) Key Exclusion Criteria: * Have clinically significant neurological or cognitive disorders affecting the CNS other than AD, as determined by the investigator * Have clinically significant psychiatric conditions * Have any history of unstable or poorly controlled endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, hematological, or other significant medical condition that, in the opinion of the investigator, may interfere with the completion or interpretation of study assessment * Have had a malignancy within 5 years before screening, except fully resected basal cell carcinoma or other malignancies (such as prostate cancer) at low risk of recurrence, depending on investigator and medical monitor agreement * Have had previous anti amyloid or anti tau immunotherapy (including active immunization) * Note: ADAD participants who have participated in previous passive anti-amyloid immunotherapy \> 6 months previously will be allowed, contingent on investigator and Sponsor agreement * Have had previous exposure to gene therapy

Where Is This Study? (1 UK site)

Clinical Site(s)

London, United Kingdom

Recruiting

How to Get in Touch

Clinical Trials at Denali Therapeutics

Sponsor contact

CONTACT

Email: clinical-trials@dnli.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06