CompletedPhase 1

Study to Evaluate DNL747 in Subjects With Alzheimer's Disease

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL747 in Subjects With Alzheimer's Disease

Lead sponsor

Denali Therapeutics Inc.

Asset

DNL747

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET/CSF)•CDR global 0.5-1•MMSE 16-26

Primary endpoints

•Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)•Clinically significant neurological examination abnormalities•Laboratory test abnormalities

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDDNLI-D-0002

NCT IDNCT03757325

Timeline

Milestones

Study first posted2018-11-28actual

Study start2019-02-13actual

Primary completion2019-12-05actual

Study completion2019-12-05actual

Last update posted2020-02-26actual

Assets

Drug assets

DNL747

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Key Inclusion Criteria:

•Women of non-childbearing potential and men, aged 55-85 years

•AD diagnosis based on the 2011 National Institute on Aging-Alzheimer's Association Guidelines

•Supportive evidence for diagnosis of AD based upon positive CSF Aβ42 test, or documented history of positive amyloid-specific PET scan

•Screening MMSE score of 16-26 points

•Screening CDR Global Score of 0.5-1.0

•Availability of a person ("caregiver") who, in the investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits that require input for scale completion, assists the participant with compliance for at-home study treatment administration, and signs the necessary consent form (note: the caregiver is not required to stay in the unit)

•Approved AD treatments (acetylcholinesterase inhibitors ± memantine) and other prescription medications must be stable for ≥1 month prior to screening and anticipated to be stable over the duration of the study

Exclusion criteria

•Clinical history within 2 years of the screening visit or current evidence of any neurological or neurodegenerative disorder other than AD that is associated with transient or sustained alterations in cognition

•Magnetic resonance imaging (MRI) at screening (or within 1 year of screening visit) consistent with any neurological or neurodegenerative disorder other than AD that is associated with transient or sustained alterations in cognition

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

Pharmacokinetic measure of CSF concentrations of DNL747