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

ConditionAlzheimer Disease, Early Onset
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDenali Therapeutics Inc.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

A Clinical Dementia Rating global score of 0.5 or 1

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • DNL628

    Drug

    Multiple ascending doses

  • Placebo

    Drug

    Multiple ascending doses

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Experimental ArmExperimental treatment 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of treatment-emergent adverse events (TEAEs) throughout the double-blind period

Time frame
37 weeks

Secondary outcomes

1

PK parameter: Maximum concentration (Cmax) of DNL628 in plasma

Time frame
37 weeks
2

PK Parameter: Time to reach maximum concentration (tmax) of DNL628 in plasma

Time frame
37 weeks
3

PK Parameter: Minimum concentration (Cmin) of DNL628 in plasma

Time frame
37 weeks
4

PK Parameter: Area under the concentration-time curve (AUC) from time zero to time of last measurable concentration (AUClast) of DNL628 in plasma

Time frame
37 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Denali Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov
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