Study Stopped
Due to an unfavorable risk-benefit ratio including no evidence of potential efficacy, and the adverse event profile of E2609 being worse than placebo.
A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease
MissionAD1
A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study With an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease
3 other identifiers
interventional
2,212
17 countries
257
Brief Summary
The name of this trial is MissionAD1. This phase 3 study consists of a Core and Open Label Extension (OLE) Phase in participants with Early Alzheimer's Disease (EAD), and will be conducted to evaluate the efficacy and safety of E2609. The Core is a 24-month treatment, multicenter, double blind, placebo controlled parallel group study. The OLE is a 24-month treatment, one group study. The data for the studies E2609-G000-301 (NCT02956486, MissionAD1) and E2609-G000-302 (NCT03036280, MissionAD2) will be pooled.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2016
Typical duration for phase_3
257 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2016
CompletedFirst Submitted
Initial submission to the registry
November 3, 2016
CompletedFirst Posted
Study publicly available on registry
November 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2020
CompletedResults Posted
Study results publicly available
February 3, 2021
CompletedFebruary 3, 2021
January 1, 2021
3.2 years
November 3, 2016
January 14, 2021
January 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Core Phase: Change From Baseline up to Month 24 in the Clinical Dementia Rating-sum of Boxes (CDR-SB) Score
The clinical dementia rating (CDR) scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3. The CDR-SB is a sum of the individual domain scores and ranges from 0 to 18. Higher score indicates more impairment.
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
A TEAE is defined as an adverse event that emerged during treatment or within 28 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the adverse event was continuous. Number of participants with TEAEs (serious and non-serious adverse events) were reported based on their safety assessments of laboratory tests, suicidal ideation and suicidal behavior, drug abuse potential, physical examination, neurological examination, regular measurement of vital signs, magnetic resonance imaging and electrocardiogram parameter values.
From first dose of study drug up to approximately 6 months (including 1 month follow up) for the extension phase
Secondary Outcomes (25)
Core Phase: Change From Baseline up to Month 24 in Alzheimer's Disease Composite Score (ADCOMS)
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Core Phase: Change From Baseline up to Month 24 in Amyloid Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR)
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Core Phase: Change From Baseline up to Month 24 in the CDR-SB Score for Participants Enriched by Baseline Amyloid PET SUVR Between 1.2 and 1.6
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Core Phase: Change From Baseline up to Month 24 in the ADCOMS for Participants Enriched by Baseline Amyloid PET SUVR Between 1.2 and 1.6
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Core Phase: Change Per Year (Mean Slope) in CDR-SB Score up to Month 24
Up to Month 24 of the core phase
- +20 more secondary outcomes
Study Arms (3)
Core Study: Elenbecestat 50 mg
EXPERIMENTALParticipants will receive one 50 milligram (mg) elenbecestat tablet, orally, once a day in the morning. The core study will be double blinded.
Core Study: Placebo
PLACEBO COMPARATORParticipants will receive one matching placebo tablet, orally, once a day in the morning. The core study will be double blinded.
Open-label Extension Phase: Elenbecestat 50 mg
EXPERIMENTALParticipants completing the core study will receive one 50 mg elenbecestat tablet, orally, once a day in the morning.
Interventions
Oral tablet.
Eligibility Criteria
You may qualify if:
- Core Study
- Mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia including
- Mini Mental State Examination score equal to or greater than 24
- Clinical Dementia Rating (CDR) global score of 0.5
- CDR Memory Box score of 0.5 or greater
- Impaired episodic memory confirmed by a list learning task
- Positive biomarker for brain amyloid pathology as indicated by either amyloid positron emission tomography or cerebrospinal fluid AD assessment or both
- Extension Phase
- Participants who complete the Core Study
You may not qualify if:
- Core Study
- Females who are breastfeeding or pregnant at Screening or Baseline. Females of child-bearing potential must use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation
- Any condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD
- Participants with a history of seizures within 5 years of Screening
- History of transient ischemic attacks or stroke within 12 months of Screening
- Psychiatric diagnosis or symptoms (example, hallucinations, major depression, delusions etc.)
- Suicidal ideation or any suicidal behavior within 6 months before Screening or has been hospitalized or treated for suicidal behavior in the past 5 years
- Have any contraindications to magnetic resonance imaging (MRI) scanning or
- Have lesions that could indicate a dementia diagnosis other than AD on brain MRI
- Exhibit other significant pathological findings on brain MRI.
- Participants who have a history of moderate to severe hepatic impairment (example, Child-Pugh Class B or C)
- Results of laboratory tests conducted during Screening that are outside the following limits:
- Absolute lymphocyte count below the lower limit of normal (LLN)
- Thyroid stimulating hormone above normal range
- Abnormally low Vitamin B12 levels
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
- Biogencollaborator
Study Sites (258)
Facility #1
Chandler, Arizona, 85226, United States
Facility #1
Colton, California, 92324, United States
Facility #1
Costa Mesa, California, 92626, United States
Facility #1
Fullerton, California, 92835, United States
Facility #1
Imperial, California, 92251, United States
Facility #1
Irvine, California, 92618, United States
Facility #1
Lemon Grove, California, 91945, United States
Facility #1
Oceanside, California, 92054, United States
Facility #2
Oceanside, California, 92054, United States
Facility #1
Oxnard, California, 93030, United States
Facility #1
Panorama City, California, 91402, United States
Facility #1
San Diego, California, 92123, United States
Facility #1
Denver, Colorado, 80218, United States
Facility #1
Atlantis, Florida, 33462, United States
Facility #1
Aventura, Florida, 33187, United States
Facility #2
Aventura, Florida, 33187, United States
Facility #1
Boynton Beach, Florida, 33437, United States
Facility #1
Coral Gables, Florida, 33134, United States
Facility #2
Coral Gables, Florida, 33134, United States
Facility #1
Delray Beach, Florida, 33445, United States
Facility #1
Doral, Florida, 33122, United States
Facility #1
Hialeah, Florida, 33016, United States
Facility #2
Miami, Florida, 33122, United States
Facility #11
Miami, Florida, 33125, United States
Facility #9
Miami, Florida, 33125, United States
Facility #10
Miami, Florida, 33126, United States
Facility #4
Miami, Florida, 33133, United States
Facility #1
Miami, Florida, 33137, United States
Facility #6
Miami, Florida, 33144, United States
Facility #3
Miami, Florida, 33155, United States
Facility #7
Miami, Florida, 33174, United States
Facility #8
Miami, Florida, 33176, United States
Facility #2
Orlando, Florida, 32801, United States
Facility #1
Orlando, Florida, 32806, United States
Facility #3
Orlando, Florida, 32807, United States
Facility #1
Palm Beach Gardens, Florida, 33410, United States
Facility #1
Pompano Beach, Florida, 33064, United States
Facility #1
Port Charlotte, Florida, 33952, United States
Facility #1
Port Orange, Florida, 32127, United States
Facility #1
Spring Hill, Florida, 34609, United States
Facility #1
Tampa, Florida, 33613, United States
Facility #2
Tampa, Florida, 33614, United States
Facility #1
The Villages, Florida, 32162, United States
Facility #1
Atlanta, Georgia, 30328, United States
Facility #1
Columbus, Georgia, 31909, United States
Facility #1
Decatur, Georgia, 30033, United States
Facility #1
Suwanee, Georgia, 30024, United States
Facility #1
Meridian, Idaho, 83642, United States
Facility #1
Northbrook, Illinois, 60062, United States
Facility #2
Wichita, Kansas, 67214, United States
Facility #1
Boston, Massachusetts, 2115, United States
Facility #1
Farmington Hills, Michigan, 48334, United States
Facility #1
Chesterfield, Missouri, 63005, United States
Facility #1
City of Saint Peters, Missouri, 63303, United States
Facility #1
O'Fallon, Missouri, 63368, United States
Facility #2
St Louis, Missouri, 63104, United States
Facility #1
Mount Arlington, New Jersey, 7856, United States
Facility #2
Springfield, New Jersey, 7081, United States
Facility #1
West Long Branch, New Jersey, 7764, United States
Facility #1
Amherst, New York, 14226, United States
Facility #1
Brooklyn, New York, 11229, United States
Facility #1
New York, New York, 10032, United States
Facility #1
Canton, Ohio, 44718, United States
Facility #1
Centerville, Ohio, 45459, United States
Facility #1
Cleveland, Ohio, 44195, United States
Facility #1
Dayton, Ohio, 45459, United States
Facility #1
Lakewood, Ohio, 44107, United States
Facility #1
Westerville, Ohio, 43081, United States
Facility #1
Oklahoma City, Oklahoma, 73116, United States
Facility #1
Portland, Oregon, 97210, United States
Facility #1
Jenkintown, Pennsylvania, 19046, United States
Facility #1
Media, Pennsylvania, 19063, United States
Facility #1
Philadelphia, Pennsylvania, 19104, United States
Facility #1
East Providence, Rhode Island, 02914, United States
Facility #1
Providence, Rhode Island, 2906, United States
Facility #1
Port Royal, South Carolina, 29935, United States
Facility #1
Cordova, Tennessee, 38018, United States
Facility #2
Nashville, Tennessee, 37203, United States
Facility #1
Nashville, Tennessee, 37212, United States
Facility #1
Austin, Texas, 78757, United States
Facility #1
Dallas, Texas, 75231, United States
Facility #1
Houston, Texas, 77084, United States
Facility #1
San Antonio, Texas, 78229-3900, United States
Facility #3
San Antonio, Texas, 78240, United States
Facility #1
Salt Lake City, Utah, 84108, United States
Facility #1
Bennington, Vermont, 5201, United States
Facility #1
Hampton, Virginia, 23666, United States
Facility #1
Madison, Wisconsin, 53705, United States
Facility #2
Caba, Buenos Aires, -1405, Argentina
Facility #1
Caba, Buenos Aires, C1012AAR, Argentina
Facility #4
Caba, Buenos Aires, C1126AAB, Argentina
Facility #3
Caba, Buenos Aires, C1427, Argentina
Facility #1
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1111, Argentina
Facility #3
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1430, Argentina
Facility #2
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1230AAZ, Argentina
Facility #1
Córdoba, Capital, X5003DCE, Argentina
Facility #1
Rosario, Santa Fe Province, 2000, Argentina
Facility #4
Buenos Aires, 1199, Argentina
Facility #5
Caba, C1428AQK, Argentina
Facility #2
Córdoba, X5004A0A, Argentina
Facility #3
Córdoba, X5009BIN, Argentina
Facility #1
Santa Fe, 3000, Argentina
Facility #1
Darlinghurst, New South Wales, 2010, Australia
Facility #1
Macquarie Park, New South Wales, 2113, Australia
Facility #1
Tumbi Vmbi, New South Wales, 2261, Australia
Facility #1
Brisbane, Queensland, 4032, Australia
Facility #1
Caulfield, Victoria, 3162, Australia
Facility #1
Geelong, Victoria, 3220, Australia
Facility #1
Heidelberg, Victoria, 3084, Australia
Facility #1
Malvern, Victoria, 3144, Australia
Facility #2
Melbourne, Victoria, Australia
Facility #1
Parkville, Victoria, 3050, Australia
Facility #1
Nedlands, Western Australia, 6009, Australia
Facility #3
Melbourne, 3146, Australia
Facility #1
Vienna, 1130, Austria
Facility #1
Pleven, 5800, Bulgaria
Facility #1
Plovdiv, 4002, Bulgaria
Facility #1
Rousse, 7002, Bulgaria
Facility #4
Sofia, 1142, Bulgaria
Facility #3
Sofia, 1309, Bulgaria
Facility #1
Sofia, 1431, Bulgaria
Facility #2
Sofia, 1431, Bulgaria
Facility #1
Kamloops, British Columbia, V2C 5T1, Canada
Facility #1
Kelowna, British Columbia, V1Y 1Z9, Canada
Facility #1
West Vancouver, British Columbia, V7T 1C5, Canada
Facility #1
Halifax, Nova Scotia, B3S 1M7, Canada
Facility #1
Kentville, Nova Scotia, B4N 4K9, Canada
Facility #1
Ottawa, Ontario, K1N 5C8, Canada
Facility #1
Peterborough, Ontario, K9H 2P4, Canada
Facility #1
Montreal, Quebec, H1M 1B1, Canada
Facility #1
Sherbrooke, Quebec, J1L 0H8, Canada
Facility #1
Hradec Králové, 500 09, Czechia
Facility #1
Kladno, 272 01, Czechia
Facility #1
Olomouc, 779 00, Czechia
Facility #1
Prague, 109 00, Czechia
Facility #1
Montpellier, Herault, 34295, France
Facility #1
Bordeaux, 33076, France
Facility #1
Bron, 69677, France
Facility #1
Marseille, 13385, France
Facility #1
Nantes, 44800, France
Facility #1
Paris, 75013, France
Facility #1
Rouen, 76000, France
Facility #1
Toulouse, 31059, France
Facility #1
Neuburg am Inn, Bavaria, 86633, Germany
Facility #1
Hoppegarten, Brandenburg, 15366, Germany
Facility #1
Oranienburg, Brandenburg, 16515, Germany
Facility #1
Frankfurt am Main, Hesse, 60528, Germany
Facility #1
Leipzig, Saxony, 4107, Germany
Facility #1
Berlin, 10245, Germany
Facility #2
Berlin, 10629, Germany
Facility #1
Gera, 7551, Germany
Facility #1
Homburg/Saar, 66241, Germany
Facility #1
Schwerin, 19053, Germany
Facility #5
Athens, 11528, Greece
Facility #4
Athens, 15123, Greece
Eisai Trial Site 1
Anjo-shi, Aichi-ken, 446-8510, Japan
Eisai Trial Site 1
Nagoya, Aichi-ken, 467-8602, Japan
Eisai Trial Site 1
Obu-shi, Aichi-ken, 474-8511, Japan
Eisai Trial Site 1
Yoshida-gun, Fukui, 910-1193, Japan
Eisai Trail Site 1
Kitakyushu-shi, Fukuoka, 808-0024, Japan
Eisai Trial Site 1
Omuta-shi, Fukuoka, 837-0911, Japan
Eisai Trial Site 1
Fujioka-shi, Gunma, 375-0017, Japan
Eisai Trial Site 1
Otake-shi, Hiroshima, 739-0651, Japan
Eisai Trial Site 1
Himeji, Hyōgo, 671-1227, Japan
Eisai Trial Site 2
Himeji-shi, Hyōgo, 670-0981, Japan
Eisai Trial Site 1
Kobe, Hyōgo, 650-0017, Japan
Facility #1
Hiragi, Kagawa-ken, 761-0793, Japan
Eisai Trial Site 3
Takamatsu, Kagawa-ken, 760-8557, Japan
Eisai Trial Site 1
Fujisawa-shi, Kanagawa, 251-0038, Japan
Eisai Trial Site 1
Kyoto, Kyoto, 602-8566, Japan
Eisai Trial Site 2
Kyoto, Kyoto, 602-8566, Japan
Eisai Trial site 5
Kyoto, Kyoto, 607-8113, Japan
Eisai Trial Site 4
Kyoto, Kyoto, 616-8255, Japan
Eisai Trial Site 1
Shimogyo-ku, Kyoto, 600-8558, Japan
Eisai Trial Site 1
Higashimorokatagun, Miyazaki, 880-1111, Japan
Eisai Trial Site 1
Kurashiki-shi, Okayama-ken, 710-0813, Japan
Eisai Trial Site 2
Kurashiki-shi, Okayama-ken, 710-8692, Japan
Eisai Trial Site 1
Okayama, Okayama-ken, 700-8557, Japan
Eisai Trial Site 2
Okayama, Okayama-ken, 701-1192, Japan
Eisai Trial Site 1
Hirakata, Osaka, 573-1121, Japan
Eisai Trial Site 1
Naniwa-Ku, Osaka, 556-0017, Japan
Eisai Trial Site 1
Osaka, Osaka, 534-0021, Japan
Eisai Trial Site 3
Osaka, Osaka, 543-8555, Japan
Eisai Trial Site 2
Osaka, Osaka, 545-8586, Japan
Eisai Trial site 2
Sakai-shi, Osaka, 593-8301, Japan
Eisai Trial Site 1
Suita-shi, Osaka, 565-0871, Japan
Eisai Trial Site 2
Suita-shi, Osaka, 565-0874, Japan
Eisai Trial Site 1
Suminoe-ku, Osaka, 559-0004, Japan
Eisai Trial Site 1
Kanzaki-gun, Saga-ken, 842-0192, Japan
Eisai Trial Site 2
Ōtsu, Shiga, 520-0832, Japan
Eisai Trial Site 1
Ōtsu, Shiga, 520-2192, Japan
Eisai Trial Site 1
Tokushima, Tokushima, 770-8503, Japan
Eisai Trial Site 1
Bunkyo-ku, Tokyo, 113-0034, Japan
Eisai Trial Site 2
Bunkyo-ku, Tokyo, 113-8603, Japan
Eisai Trial Site 1
Kodaira-shi, Tokyo, 187-8551, Japan
Eisai Trial Site 1
Minato-ku, Tokyo, 108-0073, Japan
Eisai Trial Site 1
Setagaya-ku, Tokyo, 158-8531, Japan
Eisai Trial Site 1
Shinjuku-ku, Tokyo, 169-0073, Japan
Eisai Trial Site 1
Sumida-ku, Tokyo, 130-0004, Japan
Eisai Trial Site 1
Hofu-shi, Yamaguchi, 747-0802, Japan
Eisai Trial Site 1
Kumamoto, 860-8556, Japan
Eisai Trial Site 3
Kyoto, 606-0851, Japan
Eisai Trial Site 1
Osaka, 553-0003, Japan
Facility #1
Katowice, Poland
Facility #1
Kielce, 25-411, Poland
Facility #1
Krakow, 30-149, Poland
Facility #1
Poznan, Poland
Facility #1
Poznari, 61-853, Poland
Facility #1
Siemianowice Śląskie, 41-100, Poland
Facility #1
Warsaw, 01-684, Poland
Facility #1
Guimarães, 4835-044, Portugal
Facility #1
Moscow, 119991, Russia
Facility #1
Bratislava, 85107, Slovakia
Facility #1
Bucheon-si, Gyeonggi-do, 14647, South Korea
Facility #1
Seongnam-si, Gyeonggi-do, 13620, South Korea
Facility #1
Busan, 49201, South Korea
Facility #1
Incheon, 22332, South Korea
Facility #5
Seoul, 3722, South Korea
Facility #3
Seoul, 4763, South Korea
Facility #1
Seoul, 5030, South Korea
Facility #4
Seoul, 6351, South Korea
Facility #6
Seoul, 6973, South Korea
Facility #2
Seoul, 7985, South Korea
Facility #1
Elche, Alicante, 3203, Spain
Facility #1
Palma de Mallorca, Balearic Islands, 7120, Spain
Facility #1
Sant Cugat del Vallès, Barcelona, 8195, Spain
Facility #1
Getxo, Bizkaia, 48993, Spain
Facility #1
Donostia / San Sebastian, Gipuzkoa, 20009, Spain
Facility #1
El Palmar, Murcia, 30120, Spain
Facility #1
Barcelona, 8028, Spain
Facility #2
Madrid, 28049, Spain
Facility #1
Madrid, 28223, Spain
Facility #1
Valencia, 46010, Spain
Facility #2
Valencia, 46026, Spain
Facility #1
Cambridge, Cambridgeshire, CB21 5EF, United Kingdom
Facility #1
Chester, Cheshire, CH2 1BQ, United Kingdom
Facility #1
Winwick, Warrington, Cheshire, WA2 8WA, United Kingdom
Facility #1
Plymouth, Devon, PL6 8BT, United Kingdom
Facility #1
Bournemouth, Dorset, BH1 4JQ, United Kingdom
Facility #1
Crowborough, East Sussex, TN6 1HB, United Kingdom
Facility #1
Manchester, Greater Manchester, M13 9WL, United Kingdom
Facility #1
Southampton, Hampshire, SO30 3JB, United Kingdom
Facility #1
Glasgow, Lanarkshire, G20 0XA, United Kingdom
Facility #1
Blackpool, Lancashire, FY2 0JH, United Kingdom
Facility #1
Preston, Lancashire, PR2 8DW, United Kingdom
Facility #2
London, Middlesex, TW7 6FY, United Kingdom
Facility #1
Bath, North East Somerset, BA1 3NG, United Kingdom
Facility #1
Oxford, Oxfordshire, OX3 7JX, United Kingdom
Facility #1
Aberdeen, Scotland, AB25 2ZH, United Kingdom
Facility #1
Sheffield, South Yorkshire, S5 7JT, United Kingdom
Facility #1
Leatherhead, Surrey, KT22 7AD, United Kingdom
Facility #1
Birmingham, West Midlands, B168QQ, United Kingdom
Facility #1
Swindon, Wilts, SN3 6BW, United Kingdom
Facility #2
Glasgow, G51 4TF, United Kingdom
Facility #1
Guildford, GU2 7YD, United Kingdom
Facility #1
London, W1G 9RU, United Kingdom
Facility #4
London, W6 8RF, United Kingdom
Facility #3
London, WC1X 8QD, United Kingdom
Related Publications (3)
Devanarayan V, Doherty T, Charil A, Sachdev P, Ye Y, Murali LK, Llano DA, Zhou J, Reyderman L, Hampel H, Kramer LD, Dhadda S, Irizarry MC. Plasma pTau217 predicts continuous brain amyloid levels in preclinical and early Alzheimer's disease. Alzheimers Dement. 2024 Aug;20(8):5617-5628. doi: 10.1002/alz.14073. Epub 2024 Jun 28.
PMID: 38940656DERIVEDDevanarayan V, Ye Y, Charil A, Andreozzi E, Sachdev P, Llano DA, Tian L, Zhu L, Hampel H, Kramer L, Dhadda S, Irizarry M; Alzheimer's Disease Neuroimaging Initiative (ADNI). Predicting clinical progression trajectories of early Alzheimer's disease patients. Alzheimers Dement. 2024 Mar;20(3):1725-1738. doi: 10.1002/alz.13565. Epub 2023 Dec 13.
PMID: 38087949DERIVEDBullich S, Mueller A, De Santi S, Koglin N, Krause S, Kaplow J, Kanekiyo M, Roe-Vellve N, Perrotin A, Jovalekic A, Scott D, Gee M, Stephens A, Irizarry M. Evaluation of tau deposition using 18F-PI-2620 PET in MCI and early AD subjects-a MissionAD tau sub-study. Alzheimers Res Ther. 2022 Jul 27;14(1):105. doi: 10.1186/s13195-022-01048-x.
PMID: 35897078DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early due to an unfavorable risk-benefit ratio including no evidence of potential efficacy and the adverse event profile in participants with drug treatment was worse than that in participants who received placebo. The small sample size at the 24 month time point of the core phase limits the interpretability of the data.
Results Point of Contact
- Title
- Eisai Medical Information
- Organization
- Eisai Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2016
First Posted
November 7, 2016
Study Start
October 20, 2016
Primary Completion
January 15, 2020
Study Completion
January 15, 2020
Last Updated
February 3, 2021
Results First Posted
February 3, 2021
Record last verified: 2021-01