Status:
COMPLETED
Study to Evaluate DNL747 in Subjects With Alzheimer's Disease
Lead Sponsor:
Denali Therapeutics Inc.
Conditions:
Alzheimer Disease
Eligibility:
All Genders
55-85 years
Phase:
PHASE1
Brief 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...
Detailed Description
This is a Phase 1b randomized, placebo-controlled, double-blind, crossover study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL747 in subjects with Alzhe...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
February 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03757325
Start Date
February 13 2019
End Date
December 5 2019
Last Update
February 26 2020
Active Locations (5)
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1
Clinical Site(s)
Miami, Florida, United States, 33143
2
Clinical Site(s)
Orlando, Florida, United States, 32806
3
Clinical Site(s)
Dallas, Texas, United States, 75231
4
Clinical Site(s)
Salt Lake City, Utah, United States, 84124