Recruiting

Phase 3

Observational StudyScreening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies

Sponsor:

Hoffmann-La Roche

Code:

NCT07177352

Conditions

Alzheimers Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

No Intervention

Study Details

Brief summary:

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

Conditions

Alzheimers Disease

Study ID

NCT07177352

Start date

Jul 2, 2025

Status verified date

Aug, 2026

Completion date

Jul 31, 2035

Anticipated

Primary completion date

Jul 31, 2035

Anticipated

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Ability and willingness to participate in an interventional clinical study, including meeting key eligibility criteria of linked interventional Roche AD studies (e.g., specific age ranges)
Ability and willingness to receive information about potential eligibility in an associated interventional Roche AD study

Exclusion Criteria:

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
For participants with a clinical diagnosis of MCI or mild AD: Previous AD diagnosis based on biomarker confirmation with an approved or validated rule in method (e.g., amyloid PET or cerebrospinal fluid, blood biomarker) is exclusionary

Study Design

Enrollment

80000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Screening Arm

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

Interventions

No Intervention

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

Primary outcome measure

Concentration of pTau217 in Blood on Day1 [ Time Frame: Day 1 ]
Cognitive score in ISLT on Day 1 [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: WP45722 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Banner Alzheimer?s Institute

Recruiting

Phoenix, Arizona, United States, 85006

Banner Sun Health Research Institute

Recruiting

Sun City, Arizona, United States, 85351

Sun Valley Research Center, Inc.

Recruiting

Imperial, California, United States, 92251

Inglewood Clinicals

Recruiting

Inglewood, California, United States, 90301

Irvine Center for Clinical Research

Recruiting

Irvine, California, United States, 92614

Healthy Brain Clinic

Recruiting

Long Beach, California, United States, 90804

Oakland Clinical

Recruiting

Oakland, California, United States, 94609

Riverside Clinical

Recruiting

Riverside, California, United States, 92506

Syrentis Clinical Research

Recruiting

Santa Ana, California, United States, 92705

Cenexel California Neuroscience Research, LLC

Recruiting

Sherman Oaks, California, United States, 91403

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

JEM Research LLC

Recruiting

Atlantis, Florida, United States, 33462

K2 Medical Research-Winter Garden

Recruiting

Clermont, Florida, United States, 34711

K2 Medical Research - The Villages

Recruiting

Lady Lake, Florida, United States, 32159

K2 Medical Research, LLC

Recruiting

Maitland, Florida, United States, 32751

Visionary Investigators Network- Neurology Aventura

Recruiting

Miami, Florida, United States, 33133

Renstar Medical Research

Recruiting

Ocala, Florida, United States, 34470

Charter Research - Winter Park/Orlando

Recruiting

Orlando, Florida, United States, 32803

Conquest Research - Lake Nona

Recruiting

Orlando, Florida, United States, 32832

Alzheimer's Research and Treatment Center

Recruiting

Stuart, Florida, United States, 34996

Axiom Brain Health LLC

Recruiting

Tampa, Florida, United States, 34654

Charter Research - Lady Lake/The Villages

Recruiting

The Villages, Florida, United States, 32162

Alzheimer?s Research and Treatment Center

Recruiting

Wellington, Florida, United States, 33414

Conquest Research, LLC

Recruiting

Winter Park, Florida, United States, 32789

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Alzheimer's Research and Treatment Center - Columbus

Recruiting

Columbus, Georgia, United States, 31904

Accel Research Sites-NeuroStudies

Recruiting

Decatur, Georgia, United States, 30030

CenExel iResearch, LLC

Recruiting

Decatur, Georgia, United States, 30030

Center for Advanced Research & Education

Recruiting

Gainesville, Georgia, United States, 30501

Hawaii Pacific Neuroscience

Recruiting

Honolulu, Hawaii, United States, 96817

RE:Cognition (Chicago)

Recruiting

Chicago, Illinois, United States, 60611

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

Recruiting

Chicago, Illinois, United States, 60640

Tandem Clinical Research, LLC

Recruiting

Marrero, Louisiana, United States, 70072

Adams Clinical Boston

Recruiting

Boston, Massachusetts, United States, 02116

Boston Center for Memory

Recruiting

Newton, Massachusetts, United States, 02459

Adams Clinical Watertown

Recruiting

Watertown, Massachusetts, United States, 02472

Quest Research Institute

Recruiting

Farmington Hills, Michigan, United States, 48334

Washington University School of MedicineClinical Translational Research Unit

Recruiting

St Louis, Missouri, United States, 63110

The Cognitive and Research Center of New Jersey

Recruiting

Ridgewood, New Jersey, United States, 07450

The Cognitive and Research Center of New Jersey

Recruiting

Springfield, New Jersey, United States, 07081

IMA Clinical Research - Albuquerque

Recruiting

Albuquerque, New Mexico, United States, 87109

Basil Clinical

Recruiting

Laurelton, New York, United States, 11413-2016

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10021

Adams Clinical Harlem

Recruiting

New York, New York, United States, 10029

AD-CARE, University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14620

Adams Clinical Bronx

Recruiting

The Bronx, New York, United States, 10461

Triad Clinical Trials

Recruiting

Greensboro, North Carolina, United States, 27410

Ohio State University

Recruiting

Columbus, Ohio, United States, 43221

Summit Research Network Inc.

Recruiting

Portland, Oregon, United States, 97210

Flourish Research ? Philadelphia

Recruiting

Plymouth Meeting, Pennsylvania, United States, 19462

Butler Hospital

Recruiting

Providence, Rhode Island, United States, 02906

Ralph H. Johnson VA Medical Center

Recruiting

Charleston, South Carolina, United States, 29403

Palmetto Clinical Trials

Recruiting

Summerville, South Carolina, United States, 29485

Genesis Neuroscience Clinic

Recruiting

Knoxville, Tennessee, United States, 37909

K2 Medical Research - Nashville

Recruiting

Nashville, Tennessee, United States, 37204

Gadolin Research, LLC

Recruiting

Beaumont, Texas, United States, 77702

South Texas Research Institute - Brownsville

Recruiting

Brownsville, Texas, United States, 78520

Kerwin Medical Center

Recruiting

Dallas, Texas, United States, 75216

Kerwin Research Center, LLC

Recruiting

Dallas, Texas, United States, 75231

South Texas Research Institute - Edinburg

Recruiting

Edinburg, Texas, United States, 78539

Re:Cognition Health - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Re:Cognition Health - Houston

Recruiting

Houston, Texas, United States, 77030

Mt.Olympus Medical Research

Recruiting

Katy, Texas, United States, 77450

El Faro Health and Therapeutics

Recruiting

Rio Grande City, Texas, United States, 78582

Sana Research, LLC

Recruiting

Arlington, Virginia, United States, 22205

Re:Cognition Health

Recruiting

Fairfax, Virginia, United States, 22031

National Clinical Research Inc.-Richmond

Recruiting

Richmond, Virginia, United States, 23294

Okanagan Clinical Trials

Recruiting

Kelowna, British Columbia, Canada, V1Y 1Z9

Kelowna Health and Memory Centre Ltd.

Recruiting

Kelowna, British Columbia, Canada, V1Y 5A8

Richmond Clinical Trials

Recruiting

Richmond, British Columbia, Canada, V6V 2L1

Centricity Research

Recruiting

Halifax, Nova Scotia, Canada, B3S 1N2

Parkwood Institute, Mental Health Care Building

Recruiting

London, Ontario, Canada, N6C 0A7

Bruyère Health Research Institute

Recruiting

Ottawa, Ontario, Canada, K1N 5C8

The Ottawa Memory Clinic

Recruiting

Ottawa, Ontario, Canada, K1Z 1G3

Kawartha Regional Memory Clinic

Recruiting

Peterborough, Ontario, Canada, K9H 2P4

Toronto Memory Program

Recruiting

Toronto, Ontario, Canada, M3B 2S7

Centricity East York

Recruiting

Toronto, Ontario, Canada, M4G 3E8

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Baycrest Health Sciences

Recruiting

Toronto, Ontario, Canada, M6A 2E1

Clinique Memoire de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 3B9

Genge Partners Inc.

Recruiting

Montreal, Quebec, Canada, H4A 3T2

Alpha Recherche Clinique

Recruiting

Québec, Canada, G3K 2P8

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

Early Alzheimers Disease
Mild Cognitive Impairment
Mild Dementia
Preclinical AD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-21.