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Tests treatment safety and results for Alzheimer Disease, Early Onset
Official title A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease
ClinicalTrials.gov ID: NCT07328451
What this study is testing
What is DNL628?
DNL628 is an investigational medicine, being studied as a potential treatment for alzheimer disease, early onset.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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...
- Have had a malignancy within 5 years before screening, except fully resected basal cell carcinoma or other malignancies (such as prostate cancer) at...
- 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...
See the full eligibility 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- 's-Hertogenbosch, Netherlands
- Amsterdam, Netherlands
- Zwolle, Netherlands
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 's-Hertogenbosch, Netherlands; Amsterdam, Netherlands; Zwolle, Netherlands; London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.