Screening to identify people who may qualify for Alzheimer's disease clinical programs
Master Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies as Assessed by Biomarker Status and Cognition
This screening process tries to find people with recent memory concerns, mild cognitive impairment, or early Alzheimer's who may be eligible for Roche interventional Alzheimer's trials.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 13000 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Locations | 211 sites (Birmingham, Alabama and 210 other locations) |
| Trial ID | NCT07177352 on ClinicalTrials.gov |
What this trial studies
This is a pre‑screening process used to determine who might qualify for Roche-sponsored Phase 3 interventional Alzheimer's disease trials. Potential participants provide recent memory complaint history and informant reports and typically complete brief cognitive testing and a medical history review. The process excludes people who are dependent in basic activities of daily living due to cognitive impairment, have other neurologic disorders that could explain cognitive decline, severe CNS trauma, or other serious medical conditions, and accommodates eyeglasses and hearing aids for testing. Pre‑screening is performed at participating clinical sites to create a pool of candidates for subsequent interventional studies.
Who should consider this trial
Good fit: Adults with objective or subjective memory concerns within the past year, including those with mild cognitive impairment or mild dementia due to Alzheimer's, who remain independent in basic daily activities and can complete brief cognitive assessments are ideal candidates.
Not a fit: People who are dependent in basic activities of daily living from cognitive impairment, have other known neurological diseases that explain cognitive problems, severe sensory deficits preventing testing, recent severe CNS trauma, or serious medical conditions are unlikely to benefit from this screening.
Why it matters
Potential benefit: If successful, this screening could speed matching people to appropriate Phase 3 Alzheimer's trials and increase access to potential treatments sooner.
How similar studies have performed: Pre‑screening and registry approaches have been widely used and shown to improve recruitment efficiency for Alzheimer's interventional trials, although patient benefit depends on the outcomes of the subsequent treatment studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 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. 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
Where this trial is running
Birmingham, Alabama and 210 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Banner Alzheimer?s Institute — Phoenix, Arizona, United States (Recruiting)
- Banner Sun Health Research Institute — Sun City, Arizona, United States (Recruiting)
- Sun Valley Research Center, Inc. — Imperial, California, United States (Recruiting)
- Inglewood Clinicals — Inglewood, California, United States (Recruiting)
- Irvine Center for Clinical Research — Irvine, California, United States (Recruiting)
- Healthy Brain Clinic — Long Beach, California, United States (Recruiting)
- Oakland Clinical — Oakland, California, United States (Recruiting)
- Riverside Clinical — Riverside, California, United States (Recruiting)
- Syrentis Clinical Research — Santa Ana, California, United States (Recruiting)
- Cenexel California Neuroscience Research, LLC — Sherman Oaks, California, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- JEM Research LLC — Atlantis, Florida, United States (Recruiting)
- K2 Medical Research-Winter Garden — Clermont, Florida, United States (Recruiting)
- K2 Medical Research - The Villages — Lady Lake, Florida, United States (Recruiting)
- K2 Medical Research, LLC — Maitland, Florida, United States (Recruiting)
- Visionary Investigators Network- Neurology Aventura — Miami, Florida, United States (Recruiting)
- Renstar Medical Research — Ocala, Florida, United States (Recruiting)
- Charter Research - Winter Park/Orlando — Orlando, Florida, United States (Recruiting)
- Conquest Research - Lake Nona — Orlando, Florida, United States (Recruiting)
- Alzheimer's Research and Treatment Center — Stuart, Florida, United States (Recruiting)
- Axiom Brain Health LLC — Tampa, Florida, United States (Recruiting)
- Charter Research - Lady Lake/The Villages — The Villages, Florida, United States (Recruiting)
- Alzheimer?s Research and Treatment Center — Wellington, Florida, United States (Recruiting)
- Conquest Research, LLC — Winter Park, Florida, United States (Recruiting)
- Grady Memorial Hospital — Atlanta, Georgia, United States (Recruiting)
- Alzheimer's Research and Treatment Center - Columbus — Columbus, Georgia, United States (Recruiting)
- Accel Research Sites-NeuroStudies — Decatur, Georgia, United States (Recruiting)
- CenExel iResearch, LLC — Decatur, Georgia, United States (Recruiting)
- Center for Advanced Research & Education — Gainesville, Georgia, United States (Recruiting)
- Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States (Recruiting)
- RE:Cognition (Chicago) — Chicago, Illinois, United States (Recruiting)
- Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville — Chicago, Illinois, United States (Recruiting)
- Tandem Clinical Research, LLC — Marrero, Louisiana, United States (Recruiting)
- Adams Clinical Boston — Boston, Massachusetts, United States (Recruiting)
- Boston Center for Memory — Newton, Massachusetts, United States (Recruiting)
- Adams Clinical Watertown — Watertown, Massachusetts, United States (Recruiting)
- Quest Research Institute — Farmington Hills, Michigan, United States (Recruiting)
- Washington University School of MedicineClinical Translational Research Unit — St Louis, Missouri, United States (Recruiting)
- The Cognitive and Research Center of New Jersey — Ridgewood, New Jersey, United States (Recruiting)
- The Cognitive and Research Center of New Jersey — Springfield, New Jersey, United States (Recruiting)
- IMA Clinical Research - Albuquerque — Albuquerque, New Mexico, United States (Recruiting)
- Basil Clinical — Laurelton, New York, United States (Recruiting)
- Weill Cornell Medical College — New York, New York, United States (Recruiting)
- Adams Clinical Harlem — New York, New York, United States (Recruiting)
- AD-CARE, University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
- Adams Clinical Bronx — The Bronx, New York, United States (Recruiting)
- Triad Clinical Trials — Greensboro, North Carolina, United States (Recruiting)
- Ohio State University — Columbus, Ohio, United States (Recruiting)
- Summit Research Network Inc. — Portland, Oregon, United States (Recruiting)
+161 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Reference Study ID Number: WP45722 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.