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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02791191




Registration number
NCT02791191
Ethics application status
Date submitted
1/06/2016
Date registered
6/06/2016
Date last updated
19/04/2021

Titles & IDs
Public title
A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia
Scientific title
Effect of LY3202626 on Alzheimer's Disease Progression as Measured by Cerebral ¹8F-AV-1451 Tau-PET in Mild Alzheimer's Disease Dementia
Secondary ID [1] 0 0
I7X-MC-LLCF
Secondary ID [2] 0 0
16223
Universal Trial Number (UTN)
Trial acronym
NAVIGATE-AD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY3202626
Treatment: Drugs - Placebo

Experimental: Dose 1 LY3202626 - 3 mg LY3202626 given orally once daily for 52 weeks.

Experimental: Dose 2 LY3202626 - 12 mg LY3202626 given orally once daily for 52 weeks.

Experimental: Placebo - Placebo given orally once daily for 52 weeks.


Treatment: Drugs: LY3202626
Administered orally

Treatment: Drugs: Placebo
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in ¹8F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [1] 0 0
Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores
Timepoint [3] 0 0
Baseline through Week 52
Secondary outcome [4] 0 0
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve at Steady State (AUC [T,SS]) of LY3202626
Timepoint [4] 0 0
Week 2, 4, and 12: Predose and Postdose prior to departing; Week 8 and 16: Postdose after arriving and prior to departing; Week 24: Postdose after cognitive testing
Secondary outcome [5] 0 0
Change From Baseline in Plasma Amyloid Beta Aß1-40, 1-42, and 1-x Concentration
Timepoint [5] 0 0
Baseline, Week 52
Secondary outcome [6] 0 0
Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog13)
Timepoint [6] 0 0
Baseline, Week 52
Secondary outcome [7] 0 0
Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory (ADCS-iADL)
Timepoint [7] 0 0
Baseline, Week 52
Secondary outcome [8] 0 0
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
Timepoint [8] 0 0
Baseline, Week 52

Eligibility
Key inclusion criteria
* Present with mild AD dementia based on the National Institute on Aging (NIA) and the Alzheimer's Association (AA) disease diagnostic criteria as determined by a qualified clinician approved by the Sponsor or designee.
* Mini-Mental State Examination score of 20 to 26 inclusive at screening visit.
* Has a florbetapir PET scan consistent with the presence of amyloid pathology at screening.
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Significant neurological disease affecting the central nervous system (CNS), other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
* Ocular pathology that significantly limits ability to reliably evaluate vision or the retina.
* Use of strong inducers of cytochrome P450 3A (CYP3A).
* Sensitivity to florbetapir or ¹8F-AV-1451.
* Contraindication to MRI or PET or poor venous access for blood draws.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/07/2018
Sample size
Target
Accrual to date
Final
316
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Box Hill
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Chermside
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Darlinghurst
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Erina
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Glen Iris
Recruitment hospital [6] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Heidelberg
Recruitment hospital [7] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Herston
Recruitment hospital [8] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Nedlands
Recruitment hospital [9] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Parkville
Recruitment hospital [10] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - West Perth
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
2250 - Erina
Recruitment postcode(s) [5] 0 0
3146 - Glen Iris
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
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New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
Canada
State/province [18] 0 0
Gatineau
Country [19] 0 0
Canada
State/province [19] 0 0
Ottawa
Country [20] 0 0
Canada
State/province [20] 0 0
Verdun
Country [21] 0 0
Japan
State/province [21] 0 0
Akashi
Country [22] 0 0
Japan
State/province [22] 0 0
Hachioji
Country [23] 0 0
Japan
State/province [23] 0 0
Ikeda
Country [24] 0 0
Japan
State/province [24] 0 0
Kasukabe-shi
Country [25] 0 0
Japan
State/province [25] 0 0
Kyoto
Country [26] 0 0
Japan
State/province [26] 0 0
Nagoya
Country [27] 0 0
Japan
State/province [27] 0 0
Nerima-ku
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka
Country [29] 0 0
Japan
State/province [29] 0 0
Setagaya-ku
Country [30] 0 0
Japan
State/province [30] 0 0
Takamatsu
Country [31] 0 0
Japan
State/province [31] 0 0
Tokyo
Country [32] 0 0
Japan
State/province [32] 0 0
Wako
Country [33] 0 0
Japan
State/province [33] 0 0
Yokosuka-shi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this study is to evaluate the safety and the effect on brain tau of the study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia.
Trial website
https://clinicaltrials.gov/study/NCT02791191
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02791191