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New pill aims to slow Alzheimer's before symptoms worsen

NCT ID NCT06402838

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study tests an experimental daily pill (RO7269162) in 256 people who either have brain plaques but no symptoms, or have mild memory problems due to Alzheimer's. Participants take the pill or a placebo for about 1.5 years, with regular check-ups to monitor safety and brain changes via PET scans and spinal fluid tests. The goal is to see if the drug can reduce harmful plaques and other disease markers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

256 people

The number who actually took part.

Started

May 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Body Mass Index (BMI) between 18 to 35 kg/m\^2 inclusive at screening * Participants must be either cognitively unimpaired or with a diagnosis of MCI due to AD, according to the National Institute on Aging - Alzheimer's Association (NIA - AA) research framework * Clinical Dementia Rating-Global Score (CDR-GS) of 0 or 0.5 * Positive amyloid PET scan based on a cut-off of ≥24 CL units * Availability of a person (referred as a "study partner" throughout the protocol) who: (a) has frequent and sufficient contact (e.g., minimum twice a week in-person, via telephone, video calls, by e-mail or other electronic means) with the participant, and is willing and able to provide accurate information regarding the participant's cognitive and functional abilities, signs the necessary ICF(s), and has sufficient cognitive capacity to accurately report on the participant's cognitive and functional abilities; (b) is in sufficient 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 duration of the study; and (c) is fluent in the language of the tests used at the study site. Please note that the study partner does not need to be a family member. Every effort should be made to keep the same study partner throughout the study * In case of treatment with symptomatic AD medications, dosing regimen must be stable for at least eight weeks prior to baseline Exclusion Criteria: * Any medical history or evidence of a condition other than AD that may affect cognition * History or presence of significant cardiovascular conditions and/or significant hematological disease * History or presence of chronic kidney disease and/or impaired hepatic function * Uncontrolled/poorly controlled diabetes * History of or active inflammatory bowel disease * Have received any passive or active immunotherapy (immunoglobulin) or other long-acting biologic agent that is under evaluation or approved to prevent or postpone cognitive decline administered within 1 year prior to baseline, and/or any other investigational treatment within five half-lives or 16 weeks prior to screening, whichever is longer

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer's disease

Contacts and locations

Locations

  • Aarhus Universitetshospital Skejby

    Aarhus N, 8200, Denmark

  • Ambulates Gesundheitszentrum der Charité GmbH

    Berlin, 12200, Germany

  • CHU de Rouen Hopital

    Rouen, 76031, France

  • Centro de Investigación Clínica UC-CICUC

    Santiago, 8330034, Chile

  • Charing Cross Hospital

    London, W6 8RF, United Kingdom

  • Complejo Asistencial Universitario de Salamanca

    Salamaca, Salamanca, 37007, Spain

  • ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

    Berlin, 13125, Germany

  • ETG Neuroscience Sp. z o.o.

    Warsaw, 02-777, Poland

  • EUROMEDIS Sp z o o

    Szczecin, 70-111, Poland

  • Fondazione Istituto Neurologico Mondino IRCCS

    Pavia, Lombardy, 27100, Italy

  • Fundacio ACE

    Barcelona, 08028, Spain

  • Gerontopole

    Toulouse, 31059, France

  • Groupement Hospitalier Est - Hôpital Neurologique

    Bron, 69677, France

  • Hop Guillaume Et Rene Laennec

    Saint-Herblain, 44800, France

  • Hopital B Roger Salengro

    Lille, 59037, France

  • Hospital Clinico Univ de Chile

    Santiago, Chile

  • Hospital General De Catalunya

    Sant Cugat del Vallès, Barcelona, 8195, Spain

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Dr. Peset

    Valencia, 46017, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital Universitario la Fe

    Valencia, 46026, Spain

  • Hospital Victoria Eugenia

    Seville, 41009, Spain

  • Hospital Virgen del Rocío

    Seville, 41013, Spain

  • Hôpital Lariboisière

    Paris, 75010, France

  • Hôpital Robertsau

    Strasbourg, 67000, France

  • Hôpital de la Timone

    Marseille, 13385, France

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Inha University Hospital

    Incheon, 22332, South Korea

  • Manchester Mental Health and Social Care Trust

    Manchester, M13 9WL, United Kingdom

  • NEURO-CARE Sp. z o.o. Sp. Komandytowa

    Katowice, 40-749, Poland

  • NZOZ Vitamed

    Bydgoszcz, 85-079, Poland

  • NZOZ WCA

    Wroc?aw, 53-659, Poland

  • Ospedale Cardinale Panico

    Tricase (LE), Apulia, 73039, Italy

  • Podlaskie Centrum Psychogeriatrii

    Bia?ystok, 15-756, Poland

  • Policlínica Guipuzcoa

    Donostia / San Sebastian, Guipuzcoa, 20014, Spain

  • ProNeuro Centrum Medyczne

    ?ory, 44-240, Poland

  • RE:Cognition Health

    London, W1G 8TA, United Kingdom

  • Rigshospitalet, Hukommelsesklinikken

    Koebenhavn Oe, 2100, Denmark

  • Scottish Brain Sciences

    Edinburgh, EH12 9DQ, United Kingdom

  • Senior Sp. Z O.O. Poradnia Psychogeriatryczna

    Sopot, 81-855, Poland

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • Surrey and Borders NHS Foundation Trust

    Chertsey, KT16 9AU, United Kingdom

  • Szpital Uniwersytecki w Krakowie

    Krakow, 30-688, Poland

  • TUM Klinikum rechts der Isar;Ambulanz für neurokognitive Erkrankungen

    München, 81675, Germany

  • Umberto I Policlinico di Roma-Università di Roma La Sapienza

    Rome, Lazio, 00185, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.