NCT07177352

Brief Summary

This study is a pre-screening process used to assess participants' potential eligibility for Roche interventional Alzheimer's disease studies.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
13,000

participants targeted

Target at P75+ for phase_3

Timeline
113mo left

Started Jul 2025

Longer than P75 for phase_3

Geographic Reach
14 countries

207 active sites

Status
recruiting

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 Progress8%
Jul 2025Jul 2035

Study Start

First participant enrolled

July 2, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2035

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

10.1 years

First QC Date

September 15, 2025

Last Update Submit

March 6, 2026

Conditions

Keywords

Early Alzheimers DiseaseMild Cognitive ImpairmentMild Dementia

Outcome Measures

Primary Outcomes (2)

  • Concentration of pTau217 in Blood on Day1

    Day 1

  • Cognitive score in ISLT on Day 1

    Day 1

Study Arms (1)

Screening Arm

OTHER

Participants will be assessed for their concentration of pTau217 in blood and cognitive score in the International Shopping List Test (ISLT).

Other: No Intervention

Interventions

Participants will have their blood drawn and cognitive score measured by the ISLT.

Screening Arm

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Report of objective or subjective memory concerns (by the participant and/or their informant) within the last year with or without a previous clinical diagnosis of MCI or dementia due to AD.

You may not qualify if:

  • Dependency in basic activities of daily living (bADLs) due to cognitive impairment
  • Visual or auditory impairment that would prevent them from performing the cognitive assessments (eyeglasses and hearing aids are permitted)
  • Any self-reported evidence or known diagnosis of a neurological or neurodegenerative condition that may lead to cognitive impairment other than AD
  • History of severe, clinically significant central nervous system trauma
  • Any serious medical condition that precludes a participant's safe participation and completion of a clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (207)

Banner Alzheimer?s Institute

Phoenix, Arizona, 85006, United States

RECRUITING

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

RECRUITING

Sun Valley Research Center, Inc.

Imperial, California, 92251, United States

RECRUITING

Inglewood Clinicals

Inglewood, California, 90301, United States

RECRUITING

Irvine Center for Clinical Research

Irvine, California, 92614, United States

RECRUITING

Healthy Brain Clinic

Long Beach, California, 90804, United States

RECRUITING

Oakland Clinical

Oakland, California, 94609, United States

RECRUITING

Riverside Clinical

Riverside, California, 92506, United States

RECRUITING

Syrentis Clinical Research

Santa Ana, California, 92705, United States

RECRUITING

Cenexel California Neuroscience Research, LLC

Sherman Oaks, California, 91403, United States

RECRUITING

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

JEM Research LLC

Atlantis, Florida, 33462, United States

RECRUITING

K2 Medical Research-Winter Garden

Clermont, Florida, 34711, United States

RECRUITING

K2 Medical Research - The Villages

Lady Lake, Florida, 32159, United States

RECRUITING

K2 Medical Research, LLC

Maitland, Florida, 32751, United States

RECRUITING

Visionary Investigators Network- Neurology Aventura

Miami, Florida, 33133, United States

RECRUITING

Renstar Medical Research

Ocala, Florida, 34470, United States

RECRUITING

Charter Research - Winter Park/Orlando

Orlando, Florida, 32803, United States

RECRUITING

Conquest Research - Lake Nona

Orlando, Florida, 32832, United States

RECRUITING

Alzheimer's Research and Treatment Center

Stuart, Florida, 34997, United States

RECRUITING

Axiom Brain Health LLC

Tampa, Florida, 34654, United States

RECRUITING

Charter Research - Lady Lake/The Villages

The Villages, Florida, 32162, United States

RECRUITING

Alzheimer?s Research and Treatment Center

Wellington, Florida, 33414, United States

RECRUITING

Conquest Research, LLC

Winter Park, Florida, 32789, United States

RECRUITING

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

RECRUITING

Alzheimer's Research and Treatment Center - Columbus

Columbus, Georgia, 31904, United States

RECRUITING

Accel Research Sites-NeuroStudies

Decatur, Georgia, 30030, United States

RECRUITING

CenExel iResearch, LLC

Decatur, Georgia, 30030, United States

RECRUITING

Center for Advanced Research & Education

Gainesville, Georgia, 30501, United States

RECRUITING

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

RECRUITING

RE:Cognition (Chicago)

Chicago, Illinois, 60611, United States

RECRUITING

Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville

Chicago, Illinois, 60640, United States

RECRUITING

Tandem Clinical Research, LLC

Marrero, Louisiana, 70072, United States

RECRUITING

Adams Clinical Boston

Boston, Massachusetts, 02116, United States

RECRUITING

Boston Center for Memory

Newton, Massachusetts, 02459, United States

RECRUITING

Adams Clinical Watertown

Watertown, Massachusetts, 02472, United States

RECRUITING

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

RECRUITING

Washington University School of MedicineClinical Translational Research Unit

St Louis, Missouri, 63110, United States

RECRUITING

The Cognitive and Research Center of New Jersey

Ridgewood, New Jersey, 07450, United States

RECRUITING

The Cognitive and Research Center of New Jersey

Springfield, New Jersey, 07081, United States

RECRUITING

IMA Clinical Research - Albuquerque

Albuquerque, New Mexico, 87109, United States

RECRUITING

Basil Clinical

Laurelton, New York, 11413-2016, United States

RECRUITING

Weill Cornell Medical College

New York, New York, 10021, United States

RECRUITING

Adams Clinical Harlem

New York, New York, 10029, United States

RECRUITING

AD-CARE, University of Rochester Medical Center

Rochester, New York, 14620, United States

RECRUITING

Adams Clinical Bronx

The Bronx, New York, 10461, United States

RECRUITING

Triad Clinical Trials

Greensboro, North Carolina, 27410, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43221, United States

RECRUITING

Summit Research Network Inc.

Portland, Oregon, 97210, United States

RECRUITING

Flourish Research ? Philadelphia

Plymouth Meeting, Pennsylvania, 19462, United States

RECRUITING

Butler Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 29403, United States

RECRUITING

Palmetto Clinical Trials

Summerville, South Carolina, 29485, United States

RECRUITING

Genesis Neuroscience Clinic

Knoxville, Tennessee, 37909, United States

RECRUITING

K2 Medical Research - Nashville

Nashville, Tennessee, 37204, United States

RECRUITING

Gadolin Research, LLC

Beaumont, Texas, 77702, United States

RECRUITING

South Texas Research Institute - Brownsville

Brownsville, Texas, 78520, United States

RECRUITING

Kerwin Medical Center

Dallas, Texas, 75216, United States

RECRUITING

Kerwin Research Center, LLC

Dallas, Texas, 75231, United States

RECRUITING

South Texas Research Institute - Edinburg

Edinburg, Texas, 78539, United States

RECRUITING

Re:Cognition Health - Fort Worth

Fort Worth, Texas, 76104, United States

RECRUITING

Re:Cognition Health - Houston

Houston, Texas, 77030, United States

RECRUITING

Mt.Olympus Medical Research

Katy, Texas, 77450, United States

RECRUITING

El Faro Health and Therapeutics

Rio Grande City, Texas, 78582, United States

RECRUITING

Sana Research, LLC

Arlington, Virginia, 22205, United States

RECRUITING

Re:Cognition Health

Fairfax, Virginia, 22031, United States

RECRUITING

National Clinical Research Inc.-Richmond

Richmond, Virginia, 23294, United States

RECRUITING

INECO Neurociencias Orono

Rosario, Santa Fe Province, S2000DTC, Argentina

RECRUITING

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

RECRUITING

Fundacion Scherbovsky

Mendoza, 5500, Argentina

RECRUITING

Sanatorio del Sur S.A.

San Miguel de Tucumán, T4000IDK, Argentina

RECRUITING

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

RECRUITING

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Southern Neurology

Kogarah, New South Wales, 2217, Australia

RECRUITING

KaRa Institute of Neurological Diseases

Macquarie Park, New South Wales, 2113, Australia

RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

RECRUITING

Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

RECRUITING

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

RECRUITING

Heidelberg Repatriation Hospital

Heidelberg, Victoria, 3081, Australia

RECRUITING

Alfred Health

Melbourne, Victoria, 3004, Australia

RECRUITING

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

RECRUITING

Instituto de Neurologia de Curitiba

Curitiba, Paraná, 81210-310, Brazil

RECRUITING

Clinica Clinilive ltda

Maringá, Paraná, 87013-250, Brazil

RECRUITING

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Instituto do Cerebro do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

RECRUITING

Clinica Neurologica

Joinville, Santa Catarina, 89202-190, Brazil

RECRUITING

Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*

São Bernardo do Campo, São Paulo, 09715-090, Brazil

RECRUITING

Centro de Pesquisas Clinicas - CPCLIN

São Paulo, São Paulo, 01244-030, Brazil

RECRUITING

Okanagan Clinical Trials

Kelowna, British Columbia, V1Y 1Z9, Canada

RECRUITING

Richmond Clinical Trials

Richmond, British Columbia, V6V 2L1, Canada

RECRUITING

Centricity Research

Halifax, Nova Scotia, B3S 1N2, Canada

RECRUITING

Parkwood Institute, Mental Health Care Building

London, Ontario, N6C 0A7, Canada

RECRUITING

Bruyère Health Research Institute

Ottawa, Ontario, K1N 5C8, Canada

RECRUITING

The Ottawa Memory Clinic

Ottawa, Ontario, K1Z 1G3, Canada

RECRUITING

Kawartha Regional Memory Clinic

Peterborough, Ontario, K9H 2P4, Canada

RECRUITING

Toronto Memory Program

Toronto, Ontario, M3B 2S7, Canada

RECRUITING

Centricity East York

Toronto, Ontario, M4G 3E8, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Baycrest Health Sciences

Toronto, Ontario, M6A 2E1, Canada

RECRUITING

Clinique Memoire de Montreal

Montreal, Quebec, H2X 3B9, Canada

RECRUITING

Genge Partners Inc.

Montreal, Quebec, H4A 3T2, Canada

RECRUITING

Alpha Recherche Clinique

Québec, G3K 2P8, Canada

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221002, China

RECRUITING

Beijing Friendship Hospital Affiliated of Capital University of Medical Science

Beijing, 100050, China

RECRUITING

The First Hospital of Jilin University

Changchun, 130021, China

RECRUITING

West China Hospital - Sichuan University

Chengdu, 610047, China

RECRUITING

The First Affiliated Hospital, Chongqing Medical University

Chongqing, 400016, China

RECRUITING

The second Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510000, China

RECRUITING

Guangdong General Hospital

Guangzhou, 510080, China

RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, 230022, China

RECRUITING

Zhongda Hospital Affiliated to Southeast University

Nanjing, 210009, China

RECRUITING

Nanjing Brain Hospital

Nanjing, 210029, China

RECRUITING

Nanjing First Hospital

Nanjing, 210029, China

RECRUITING

Huashan Hospital, Fudan University

Shanghai, 200040, China

RECRUITING

Shanghai First People's Hospital

Shanghai, 200080, China

RECRUITING

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200127, China

RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, 215004, China

RECRUITING

Aalborg Universitetshospital

Aalborg, 9000, Denmark

RECRUITING

Aarhus Universitetshospital Skejby

Aarhus N, 8200, Denmark

RECRUITING

Rigshospitalet, Hukommelsesklinikken

København Ø, 2100, Denmark

RECRUITING

A. O. U. Federico II

Naples, Campania, 80131, Italy

RECRUITING

Policlinico Universitario Agostino Gemelli

Rome, Lazio, 00168, Italy

RECRUITING

Fondazione Santa Lucia IRCCS

Rome, Lazio, 00179, Italy

RECRUITING

Umberto I Policlinico di Roma-Università di Roma La Sapienza

Rome, Lazio, 00185, Italy

RECRUITING

Ospedale Isola Tiberina - Gemelli Isola

Rome, Lazio, 00186, Italy

RECRUITING

Irccs A.O.U.San Martino Ist

Genoa, Liguria, 16132, Italy

RECRUITING

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, 25100, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

RECRUITING

AOU Policlinico Giaccone

Palermo, Sicily, 90129, Italy

RECRUITING

AO di Perugia - Ospedale S. Maria della Misericordia

Perugia, Umbria, 06156, Italy

RECRUITING

Brain Attack Center Ota Memorial Hospital

Hiroshima, 720-0825, Japan

RECRUITING

National Hospital Organization Hiroshima-Nishi Medical Center

Hiroshima, 739-0696, Japan

RECRUITING

Kobe University Hospital

Hyōgo, 650-0017, Japan

RECRUITING

Kagawa University Hospital

Kagawa, 761-0793, Japan

RECRUITING

Kochi Medical School Hospital

Kochi, 783-8505, Japan

RECRUITING

Kyoto University Hospital

Kyoto, 606-8507, Japan

RECRUITING

National Hospital Organization Utano National Hospital

Kyoto, 616-8255, Japan

RECRUITING

Mishuku Hospital

Meguro-Ku, 153-0051, Japan

RECRUITING

Mie University Hospital

Mie, 514-8507, Japan

RECRUITING

Okayama City Hospital

Okayama, 700-8557, Japan

RECRUITING

Rijikai Medical Corporation Katayama Medical Clinic

Okayama, 710-0813, Japan

RECRUITING

Kotobuki Social Medical Corporation Tominaga Clinic

Osaka, 556-0015, Japan

RECRUITING

Memory Clinic Ochanomizu

Tokyo, 113-0034, Japan

RECRUITING

The University of Tokyo Hospital

Tokyo, 113-8655, Japan

RECRUITING

Keio University Hospital

Tokyo, 160-8582, Japan

RECRUITING

Higashi-Shinjuku Clinic

Tokyo, 169-0072, Japan

RECRUITING

Tokyo Metropolitan Geriatric Hospital

Tokyo, 173-0015, Japan

RECRUITING

National Center of Neurology and Psychiatry

Tokyo, 187-8551, Japan

RECRUITING

Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Tokyo, 190-8531, Japan

RECRUITING

P-One Clinic

Tokyo, 192-0071, Japan

RECRUITING

Yamagata Tokusyukai Hospital

Yamagata, 990-0834, Japan

RECRUITING

ProNeuro Centrum Medyczne

?ory, 44-240, Poland

RECRUITING

Uniwersytet Medyczny w Lodzi

?ód?, 92-216, Poland

RECRUITING

Syberka-ClinHouse Sp. z o.o.

B?dzin, 42-500, Poland

RECRUITING

Podlaskie Centrum Psychogeriatrii

Bia?ystok, 15-756, Poland

RECRUITING

Centrum Medyczne Neuromed Sp. z.o.o.

Bydgoszcz, 85-163, Poland

RECRUITING

Centrum Badan Klinicznych PI-House sp. z o.o.

Gda?sk, 80-546, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne;Klinika Neurologii Doros?ych

Gdansk, 80-214, Poland

RECRUITING

Neuro-Care Gabriela Klodowska

Katowice, 40-749, Poland

RECRUITING

Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

RECRUITING

Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

Krakow, 31-505, Poland

RECRUITING

Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

Lublin, 20-410, Poland

RECRUITING

Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa

Późna, 61-731, Poland

RECRUITING

Nmedis sp. z o.o.

Rzeszów, 35-323, Poland

RECRUITING

Centrum Medyczne Medyk

Rzeszów, 35-326, Poland

RECRUITING

Senior Sp. Z O.O. Poradnia Psychogeriatryczna

Sopot, 81-855, Poland

RECRUITING

O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie

Ścinawa, 59-330, Poland

RECRUITING

Centrum Medyczne NeuroProtect

Warsaw, 01-684, Poland

RECRUITING

ETG Neuroscience Sp. z o.o.

Warsaw, 02-677, Poland

RECRUITING

Centrum Leczenia Zaburzen Pamieci

Warsaw, 03-839, Poland

RECRUITING

NZOZ WCA

Wroc?aw, 53-659, Poland

RECRUITING

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa SzyszkoSUM w Katowicach

Zabrze, 41-800, Poland

RECRUITING

University of Puerto Rico - Medical Science Campus

San Juan, 00935, Puerto Rico

RECRUITING

Chonnam National University Hospital

Gwangju, 61469, South Korea

RECRUITING

St. Vincent's Hospital

Gyeonggi-do, 442-723, South Korea

RECRUITING

Inha University Hospital

Incheon, 22332, South Korea

RECRUITING

Gachon University Gil Medical Center

Namdong-gu, 21565, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, 13605, South Korea

RECRUITING

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Ewha Womans University Hospital (Seoul)

Seoul, 07804, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Ajou University Medical Center

Suwon, 16499, South Korea

RECRUITING

Hospital de Dénia;Servicio de Neurología

Denia, Alicante, 03700, Spain

RECRUITING

Fundació Hospitalàries Martorell;Neurology

Martorell, Barcelona, 08760, Spain

RECRUITING

Hospital Mutua De Terrasa

Terrassa, Barcelona, 08221, Spain

RECRUITING

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Fundación ACE

Barcelona, 08028, Spain

RECRUITING

Hospital Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, 14011, Spain

RECRUITING

Policlínica Guipuzkoa

Donosti-San Sebastián, 20014, Spain

RECRUITING

Hospital San Cecilio

Granada, 18016, Spain

RECRUITING

Hospital Universitario de la Princesa

Madrid, 28006, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Hospital Universitario Dr. Peset

Valencia, 46017, Spain

RECRUITING

Hospital Universitario la Fe

Valencia, 46026, Spain

RECRUITING

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Neurology

Kwei Shen, 33305, Taiwan

RECRUITING

Taipei Medical University - Shuang Ho Hospital - Neurology

New Taipei City, 23561, Taiwan

RECRUITING

China Medical University Hospital

North Dist., 40447, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: WP45722 https://forpatients.roche.com/

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2025

First Posted

September 17, 2025

Study Start

July 2, 2025

Primary Completion (Estimated)

July 31, 2035

Study Completion (Estimated)

July 31, 2035

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations