A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)
2021年3月22日 更新者：Eli Lilly and Company
Effect of LY3202626 on Alzheimer's Disease Progression as Measured by Cerebral ¹⁸F-AV-1451 Tau-PET in Mild Alzheimer's Disease Dementia
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.
調査の概要
研究の種類
介入
入学 (実際)
316
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Irvine、California、アメリカ、92614
- Irvine Clinical Research Center
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Sacramento、California、アメリカ、95816
- Sutter Medical Group
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San Diego、California、アメリカ、92123
- Sharp Mesa Vista Hospital
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San Diego、California、アメリカ、92103
- Pacific Research Network Inc
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San Francisco、California、アメリカ、94114
- Ray Dolby Brain Health Center/Sutter Health/CPMC
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Santa Ana、California、アメリカ、92705
- Syrentis Clinical Research
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Sebastopol、California、アメリカ、95472
- North Bay Neuroscience Institute
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Connecticut
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Stamford、Connecticut、アメリカ、06905
- New England Institute for Clinical Research
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Delaware
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Wilmington、Delaware、アメリカ、19801
- Christiana Care Health Service
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Florida
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Jacksonville、Florida、アメリカ、32256
- Clinical Neuroscience Solutions Inc
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Melbourne、Florida、アメリカ、32940
- Compass Research
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Miami、Florida、アメリカ、33175
- New Horizon Research Center
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Miami、Florida、アメリカ、33173
- Florida International Research Center
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Miami、Florida、アメリカ、33176
- The Neurology Research Group, LLC
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New Port Richey、Florida、アメリカ、34652
- Suncoast Clinical Research
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Ocala、Florida、アメリカ、34470
- Renstar Medical Research
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Ocoee、Florida、アメリカ、34761
- Sensible Healthcare
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Spring Hill、Florida、アメリカ、34609
- Meridien Research
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Tampa、Florida、アメリカ、33609
- Axiom Research
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Georgia
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Gainesville、Georgia、アメリカ、30501
- United Osteoporosis Center
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Indiana
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Fort Wayne、Indiana、アメリカ、46804
- Fort Wayne Neurological Center
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Indianapolis、Indiana、アメリカ、46202
- Indiana University School of Medicine
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Kansas
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Topeka、Kansas、アメリカ、66606
- Cotton O'Neil Clinic
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Wichita、Kansas、アメリカ、67205
- Heartland Research Associates
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Maryland
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Baltimore、Maryland、アメリカ、21224
- Johns Hopkins University School of Medicine
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Massachusetts
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Newton、Massachusetts、アメリカ、02459
- Boston Center for Memory
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Missouri
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Bolivar、Missouri、アメリカ、65613
- Missouri Memory Center
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Chesterfield、Missouri、アメリカ、63005
- Clinical Research Professionals
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Creve Coeur、Missouri、アメリカ、63141
- Millenium Psychiatric Associates LLC
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Kansas City、Missouri、アメリカ、64111
- St Lukes Hospital
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Saint Louis、Missouri、アメリカ、63108
- Washington University School of Medicine
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Nevada
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Las Vegas、Nevada、アメリカ、89113
- Las Vegas Medical Research
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New Jersey
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Eatontown、New Jersey、アメリカ、07724
- Memory Enhancement Center of America, Inc.
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Monroe、New Jersey、アメリカ、08831
- Pyramid Clinical Research
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Toms River、New Jersey、アメリカ、08755
- Advanced Memory Research Institute of New Jersey
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Toms River、New Jersey、アメリカ、08755
- Bio Behavioral Health
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New York
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Albany、New York、アメリカ、12206
- Albany Medical College
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Amherst、New York、アメリカ、14226
- Dent Neurological Institute
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Ohio
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Centerville、Ohio、アメリカ、45459
- Valley Medical Primary Care
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Dayton、Ohio、アメリカ、45417
- University of Cincinnati Health Neurology
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Dayton、Ohio、アメリカ、45459
- Neurology Diagnostics, Inc.
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Shaker Heights、Ohio、アメリカ、44122
- Insight Clinical Trials
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Pennsylvania
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Abington、Pennsylvania、アメリカ、19090
- Abington Neurological Associates
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Allentown、Pennsylvania、アメリカ、18104
- Lehigh Center For Clinical Research
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Jenkintown、Pennsylvania、アメリカ、19046
- Clinical Trial Center, LLC, Psychiatry
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South Carolina
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Charleston、South Carolina、アメリカ、29406
- Clinical Trials of South Carolina
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Texas
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Dallas、Texas、アメリカ、75231
- Baylor AT&T Memory Center
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Houston、Texas、アメリカ、77030
- Nantz National Alzheimer Center
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Houston、Texas、アメリカ、77054
- University of Texas Health Services Center - Houston
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Box Hill、オーストラリア、3128
- 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.
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Chermside、オーストラリア、4032
- 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.
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Darlinghurst、オーストラリア、2010
- 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.
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Erina、オーストラリア、2250
- 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.
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Glen Iris、オーストラリア、3146
- 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.
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Heidelberg、オーストラリア、3084
- 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.
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Herston、オーストラリア、4029
- 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.
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Nedlands、オーストラリア、6009
- 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.
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Parkville、オーストラリア、3050
- 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.
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West Perth、オーストラリア、6005
- 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.
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Gatineau、カナダ、J8T 8J1
- 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.
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Ottawa、カナダ、KIN 5C8
- 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.
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Verdun、カナダ、H4H 1R3
- 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.
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Akashi、日本、673-0891
- 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.
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Hachioji、日本、193-0998
- 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.
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Ikeda、日本、563-0058
- 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.
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Kasukabe-shi、日本、344-0036
- 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.
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Kyoto、日本、606-0851
- 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.
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Nagoya、日本、451-8511
- 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.
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Nerima-ku、日本、179-0072
- 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.
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Osaka、日本、533-0004
- 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.
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Osaka、日本、559-0004
- 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.
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Setagaya-ku、日本、158-8531
- 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.
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Takamatsu、日本、760-8557
- 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.
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Tokyo、日本、156-0041
- 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.
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Wako、日本、351-0111
- 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.
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Yokosuka-shi、日本、238-0042
- 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.
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
55年～85年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Dose 1 LY3202626
3 mg LY3202626 given orally once daily for 52 weeks.
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経口投与
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実験的：Dose 2 LY3202626
12 mg LY3202626 given orally once daily for 52 weeks.
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経口投与
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実験的：Placebo
Placebo given orally once daily for 52 weeks.
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経口投与
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
時間枠：Baseline, Week 52
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The 18F-AV-1451 PET tracer assesses change from baseline in the pharmacodynamic effect of 3 mg and 12 mg doses of LY3202626 in participants with mild Alzheimer's disease (AD), compared with placebo at Week 52.The SUVr of ¹⁸F-AV-1451 was modeled using analysis of covariance (ANCOVA) to include the fixed, categorical effects of treatment dose, and the continuous, fixed covariate of baseline Tau PET SUVr and age at baseline.
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Baseline, Week 52
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
時間枠：Week 52
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Percentage of participants with treatment-emergent MRI findings at Week 52 are summarized here.
The mixed-effect model for repeated measures (MMRM) analysis was adjusted for fixed effects of treatment, visit (categorical covariate), treatment-by-visit interaction, baseline age, baseline score (continuous covariate) and baseline-by-visit interaction.
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Week 52
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Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
時間枠：Week 52
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Percentage of participants with presence of amyloid-related imaging abnormalities-edema (ARIA-E, also known as vasogenic edema) and percentage of an increase in amyloid-related imaging abnormalities-hemorrhage (ARIA-H, also known as also known as microhemorrhage) at Week 52 are summarized here.
The mixed-effect model for repeated measures (MMRM) analysis was adjusted for fixed effects of treatment, visit (categorical covariate), treatment-by-visit interaction, baseline age, baseline score (continuous covariate) and baseline-by-visit interaction.
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Week 52
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Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores
時間枠：Baseline through Week 52
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The Columbia-Suicide Severity Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors.
Suicidal ideation is defined as a "yes" answer to any 1 of 5 suicidal ideation questions, which includes a wish to be dead and 4 different categories of active suicidal ideation.
Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present during the period up through randomization.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
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Baseline through Week 52
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Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve at Steady State (AUC [T,SS]) of LY3202626
時間枠：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
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PK: AUC [T,SS] of LY3202626
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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
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Change From Baseline in Plasma Amyloid Beta Aβ₁-₄₀, ₁-₄₂, and 1-x Concentration
時間枠：Baseline, Week 52
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A mixed model repeated measures (MMRM) analysis will be used to evaluate the change from baseline to Week 52 in plasma Aβ₁-₄₀, Aβ₁-₄₂, and Aβ 1-x.
The model for the fixed effects will include terms for the following independent effects: log transformed baseline plasma Aβ, treatment, visit, treatment-by-visit interaction.
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Baseline, Week 52
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Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog₁₃)
時間枠：Baseline, Week 52
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The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD.
The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation.
The ADAS--Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity.
A mixed model repeated measures (MMRM) was used in analysis.
The model included fixed, categorical effects of treatment, visit and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
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Baseline, Week 52
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Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory (ADCS-iADL)
時間枠：Baseline, Week 52
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The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver.
The ADCS-ADL measures both basic and instrumental activities (instrumental activity items 7-23) of daily living by participants.
The range for the ADCS-iADL is 0-56 with higher scores reflecting better performance.
ADCS-iADL was analyzed using mixed-model repeated measures (MMRM), Least Square (LS) Mean was controlled for treatment, visit, treatment-by-visit interaction, baseline age, baseline score and baseline-by-visit interaction.
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Baseline, Week 52
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Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
時間枠：Baseline, Week 52
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The iADRS comprises scores form the ADAS-Cog and the ADCS-iADL.
The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 9score range 0 to 85 with higher scores reflecting worse performance and the ADCS-iADL (score range 0-56 with higher scores reflecting better performance).
The iADRS score ranges from 0 to 141 with lower scores indicating worse performance.
iADRS was analyzed using mixed-model repeated measures (MMRM); Least Square (LS) Mean was controlled for treatment, visit, treatment-by-visit interaction, baseline age, baseline score and baseline-by-visit interaction.
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Baseline, Week 52
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年6月16日
一次修了 (実際)
2018年7月2日
研究の完了 (実際)
2018年7月2日
試験登録日
最初に提出
2016年6月1日
QC基準を満たした最初の提出物
2016年6月1日
最初の投稿 (見積もり)
2016年6月6日
学習記録の更新
投稿された最後の更新 (実際)
2021年4月19日
QC基準を満たした最後の更新が送信されました
2021年3月22日
最終確認日
2021年3月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 16223
- I7X-MC-LLCF (その他の識別子：Eli Lilly and Company)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD 共有時間枠
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD 共有アクセス基準
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。