Clinical Trial Details

NCT ID: NCT03114657
Date Last Changed: September 25, 2017

Overview

Research Study Summary

A Phase 3 clinical study for patients with Alzheimer's Disease

Research Study Title

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease

Purpose

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (q4w) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
50 to 85 Years
Overall Status
Recruiting
Lead Sponsor
Hoffmann-La Roche
Duration
55 Months
Facility Type
N/A
Compensation

Eligibility

All ages 50 Years to 85 Years

Inclusion Criteria:

  • Weight between 40 and 120 kilograms (kg), inclusive

  • Availability of a person (referred to as the "caregiver") who in the investigator's judgment : (a) Has frequent and sufficient contact with the participant to be able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits (which require partner input for scale completion), signs the necessary consent form, and has sufficient cognitive capacity to accurately report upon the participant's behavior and cognitive and functional abilities; (b) Is in sufficiently good general health to have a high likelihood of maintaining the same level of interaction with the participant and participation in study procedures throughout the study duration

  • Fluency in the language of the tests used at the study site

  • Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)

  • Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid (CSF) amyloid beta 1-42 levels as measured on the Elecsys beta-amyloid (1-42) test system or amyloid positron emission tomography (PET) scan by qualitative read by the core/central PET laboratory

  • Demonstrated abnormal memory function at early screening (up to 4 weeks before screening begins) or at screening

  • Evidence of retrospective decline confirmed by a diagnosis verification form

  • Mild symptomatology, as defined by a screening MMSE score of > =22 points and CDR-GS of 0.5 or 1.0

  • Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment [MCI])

  • If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening

  • Participant must have completed at least 6 years of formal education after the age of 5 years

  • For enrollment into the China Extension Phase, participants must have residence in the People's Republic of China

Exclusion Criteria:

  • Any evidence of a condition other than AD that may affect cognition, including but not limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson's disease, corticobasal degeneration, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal degeneration, Huntington's disease, normal pressure hydrocephalus, seizure disorder, or hypoxia

  • History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder

  • At risk of suicide in the opinion of the investigator

  • Presence of significant cerebral vascular pathology as assessed by MRI central reader

  • Unstable or clinically significant cardiovascular, kidney or liver disease

  • Uncontrolled hypertension

  • Screening hemoglobin A1c (HbA1C) greater than ( > ) 8 percent (%)

  • Poor peripheral venous access

  • History of cancer except if considered to be cured or If not being actively treated with anti-cancer therapy or radiotherapy

  • Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins

Site Locations (108)

Country State City Zip Facility and Contact
United States Arizona Scottsdale 85258 Imaging End Points Clinical Research
United States Arizona Tempe 85282 Radiant Research, Inc.
United States Arkansas Fayetteville 72703 Health Initiatives Research, PLLC
United States Arkansas Little Rock 72205 Clinical Trials Inc.
United States California Carlsbad 92011 The Research Center of Southern California, LLC
United States California Costa Mesa 92626 ATP Clinical Research, Inc
United States California Laguna Hills 92653 Senior Clinical Trials
United States California Redlands 92374 Anderson Clinical Research, Inc.
United States Colorado Colorado Springs 80910 MCB Clinical Research Centers
United States Connecticut Stamford 06905 KI Health Partners, LLC; New England Institute for Clinical Research
United States Florida Atlantis 33462 JEM Research LLC
United States Florida Bradenton 34205 Bradenton Research Center
United States Florida Fort Myers 33912 Neuropsychiatric Research; Center of Southwest Florida
United States Florida Lake Worth 33449 Alzheimer's Research and Treatment Center
United States Florida Ocala 34471 Renstar Medical Research
United States Florida Saint Petersburg 33709 Meridien Research
United States Georgia Columbus 31909 Columbus Memory Center
United States Idaho Meridian 83642 Advanced Clinical Research
United States Kansas Topeka 66606 Cotton O'Neil Clinical Research Center
United States Massachusetts Winchester 01890 Alzheimers Disease Center; Neurology
United States New Jersey Toms River 08755 Advanced Memory Research Institute of NJ
United States North Carolina Greensboro 27401 Guilford Neurologic Associates
United States North Carolina Raleigh 27612 Wake Research Associates
United States Ohio Cincinnati 45011 Carl and Edyth Lindner Center at Christ Hospital
United States Ohio Columbus 43210 Ohio State University; College of Medicine
United States Oklahoma Oklahoma City 73103 Ips Research Company
United States Oregon Portland 97210 Summit Research Network Inc.
United States Pennsylvania Plains 18705 Northeastern Pennsylvania Memory
United States Pennsylvania Willow Grove 19090 Abington Neurological Associates
United States Tennessee Cordova 38018 Neurology Clinic PC
United States Texas Austin 78757 Senior Adults Specialty Research
United States Texas Beaumont 77701 Gadolin Research, LLC
United States Texas DeSoto 75115 InSite Clinical Research
United States Texas San Antonio 78229 Clinical Trials of Texas, Inc
United States Virginia Norfolk 23510 Sentara Medical Group
United States Virginia Richmond 23294 National Clinical Research Inc.-Richmond
United States Washington Spokane 99204 Frontier Institute
Australia New South Wales Darlinghurst 2010 St Vincent's Hospital Sydney
Australia New South Wales Erina 2250 Central Coast Neurosciences Research
Australia Victoria Parkville 3050 Royal Melbourne Hospital; Department of Neurology
Belgium Kortrijk 8500 AZ Groeninge (Kennedylaan)
Belgium Leuven 3000 UZ Leuven Gasthuisberg
Canada British Columbia Kelowna V1Y 2H4 Okanagan Clinical Trials
Canada Ontario Burlington L7M 4Y1 Jbn Medical Diagnostic Services Inc.
Canada Quebec Gatineau J9J 0A5 Clinique NeuroOutaouais
Canada Quebec Greenfield Park J4V 2J2 Clinique Neuro Rive-Sud
Canada Quebec G3K 2P8 ALPHA Recherche Clinique
Estonia Tallinn 10617 Laane-Tallinna Keskhaigla
France Colmar 68000 Hôpital de Jour du Centre pour Personnes Âgées; Louis Pasteur Neurologie
France Lille 59037 Hopital Roger Salengro; Service de Neurologie
France Villeurbanne 69100 Hopital des Charpennes
Israel Ramat Gan 5262100 Sheba Medical Center; Psychiatry Department
Israel Tel Aviv 6423906 Tel Aviv Sourasky Medical Center; Department of Neurology
Italy Lombardia Brescia 25125 IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer
Italy Lombardia Castellanza 21053 Irccs Multimedica Santa Maria; Unita' Di Neurologia
Italy Lombardia Milano 20132 IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria
Italy Lombardia Milano 20133 Fondazione IRCCS Istituto Nazionale Neurologico Besta; UO Neuropatologia
Italy Molise Pozzilli 86077 IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
Korea, Republic of Busan 49201 Dong-A University Hospital
Korea, Republic of Gyeonggi-do 13620 Seoul National University Bundang Hospital
Korea, Republic of Incheon 21565 Gachon University Gil Medical Center
Korea, Republic of Seoul 04763 Hanyang University Seoul Hospital
Korea, Republic of Seoul 06351 Samsung Medical Center
Korea, Republic of Seoul 06591 Seoul St Mary's Hospital
Norway Lørenskog 1478 Akershus universitetssykehus HF; Nevroklinikken S203
Norway Oslo 0450 Oslo universitetssykehus HF Ullevål sykehus; Hukommelsesklinikken
Peru Lima 15001 Clinica Internacional; Unidad De Investigacion
Peru Lima Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
Poland Bydgoszcz 85-796 NZOZ Dom Sue Ryder
Poland Szczecin 70-111 Centrum Medyczne Euromedis Sp. z o.o.
Poland Wrocław 53-139 NZOZ WCA
Portugal Braga 4710-243 Hospital de Braga; Servico de Neurologia
Portugal Porto 4099-001 Hospital Geral de Santo Antonio; Servico de Neurologia
Russian Federation Sankt Petersburg Saint-Petersburg 194356 LLC Baltic Medicine
Russian Federation Sverdlovsk Yekaterinburg 620030 State Healthcare Institution of Sverdlovsk Region Sverdlovsk Regional Clinical Psychiatric Hospita
Russian Federation Moscow 115522 Institution of RAMS (Mental Health Research Center of RAMS)
Russian Federation Nizhny Novgorod 603155 City Clinical Psychiatry Hospital #1
Russian Federation St Petersburg 190121 St Nicolas Psychiatric Hospital; Chair of Psychiatry and Narcology of St. Petersburg Medical Academy
Russian Federation Tomsk 634009 Nebbiolo Center for Clinical Trials
South Africa Cape Town 7550 Flexivest Fourteen Research Centre
South Africa Johannesburg 2196 Private Practice; the Osteoporosis Clinic
Spain Alicante Elche 03203 Hospital General Universitario de Elche; Servicio de Neurología
Spain Girona Salt 17090 Hospital Santa Caterina, Unitat de Valoració de la memoria i les demencies
Spain Guipuzcoa Donosti-San Sebastián 20014 Policlínica Guipuzkoa; Servicio de Neurología
Spain La Coruña Santiago de Compostela 15706 Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Neurologia
Spain La Rioja Logroño 26006 Hospital San Pedro; Servicio de Neurología
Spain Barcelona 08025 Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
Spain Barcelona 08036 Hospital Clinic i Provincial; Servicio de Neurologia
Spain Castellon 12004 Hospital la Magdalena; Servicio de Neurologia
Spain Cordoba 14011 Hospital Universitario Reina Sofia; Servicio de Neurologia
Spain Madrid 28034 Hospital Ramon y Cajal; Servicio de Neurologia
Spain Sevilla 41009 Hospital Universitario Virgen Macarena; Servicio de Neurologia
Taiwan Changhua County 500 Changhua Christian Hospital; Neurology
Taiwan Kaohsiung 807 Kaohsiung Medical University Hospital; Neurology
Turkey Ankara 06100 Ankara University School of Medicine; Neurology
Turkey Antalya 07058 Akdeniz University School of Medicine, Neurology Department
Turkey Kocaeli 41380 Kocaeli University Hospital; Department of Neurology
United Kingdom Bath BA1 3NG The Rice Centre; Royal United Hospital
United Kingdom Cheltenham GL53 9DZ The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre
United Kingdom Dundee DD12 9SY Ninewells Hospital
United Kingdom Edinburgh EH4 2XU NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
United Kingdom Glasgow G51 4TF Queen Elizabeth University Hospital; Clinical Research Facility
United Kingdom Kilmarnock KA2 0BE Crosshouse Hospital; NHS Ayrshire & Arran
United Kingdom London W1G 9RU RE:Cognition Health
United Kingdom Sheffield S10 2JF Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust
United Kingdom Southampton SO166YD University Southampton NHS Foundation Trust; Wessex Neurologica Centre
United Kingdom Stoke on Trent ST4 6QG University Hospital North Midlands
United Kingdom Surrey GU2 7YD Re:Cognition Health Guildford

Contact

Reference Study ID Number: BN29553 www.roche.com/about_roche/ roche_worldwide.htm
888-662-6728 (U.S. and Canada)
E-mail:

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