Overview

Study to Evaluate DNL747 in Subjects With Alzheimer's Disease

Status:
Completed
Trial end date:
2019-12-05
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL747 in subjects with Alzheimer's disease when administered for 29 days in a cross-over design
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Denali Therapeutics Inc.
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

Key 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