Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial is recruiting people who either are at risk of AD - have build-up of beta-amyloid, but have no clinical symptoms, or with a diagnosis of mild cognitive impairment. People can take part if they have a certain level of plaques (beta-amyloid) in the brain, shown by a positron emission tomography (PET) scan, a medical imaging technique in which tracers are injected to visualize specific pathological processes in the brain. People who take part in this clinical trial (participants) will be given RO7269162 OR placebo for up to about 1 and a half years. The clinical trial team will see them every 3 weeks in the first 3 months and then every 6 weeks until the end of the trial. These hospital visits will include checks to see how the participant responds to the treatment and any side effects they may have. The total time of participation in the clinical trial will be 90 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO7269162 | Experimental | Participants will receive daily doses of RO7269162 for up to 72 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive daily doses of placebo for up to 72 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7269162 | Drug | Participants will receive daily doses (one of three dose levels) of RO7269162 for up to 72 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | up to week 72 | |
| Change from baseline in brain amyloid load, as measured by amyloid positron emission tomography ( PET) scan | Baseline to Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Aβ37 in cerebrospinal fluid (CSF) | Baseline to Week 72 | |
| Change from baseline in Aβ38 in CSF | Baseline to Week 72 | |
| Change from baseline in Aβ40 in CSF |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in p-tau 217 in plasma | Baseline to Week 72 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Investigación Clínica UC-CICUC | Santiago | 8330034 | Chile | |||
| Hospital Clinico Univ de Chile |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Participants will receive daily doses of placebo for up to 72 weeks. |
|
| Baseline to Week 72 |
| Change from baseline in Aβ42 in CSF | Baseline to Week 72 |
| Change from baseline in Aβ40 in plasma | Baseline to Week 72 |
| Change from baseline in Aβ42 in plasma | Baseline to Week 72 |
| Plasma concentrations of RO7269162 | Baseline to Week 72 |
| CSF concentrations of RO7269162 | Baseline to Week 72 |
| Santiago |
| Chile |
| Aarhus Universitetshospital Skejby | Aarhus N | 8200 | Denmark |
| Rigshospitalet, Hukommelsesklinikken | Koebenhavn Oe | 2100 | Denmark |
| Groupement Hospitalier Est - Hôpital Neurologique | Bron | 69677 | France |
| Hopital B Roger Salengro | Lille | 59037 | France |
| Hôpital de la Timone | Marseille | 13385 | France |
| Hôpital Lariboisière | Paris | 75010 | France |
| CHU de Rouen Hopital | Rouen | 76031 | France |
| Hop Guillaume Et Rene Laennec | Saint-Herblain | 44800 | France |
| Hôpital Robertsau | Strasbourg | 67000 | France |
| Gerontopole | Toulouse | 31059 | France |
| Ambulates Gesundheitszentrum der Charité GmbH | Berlin | 12200 | Germany |
| ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic | Berlin | 13125 | Germany |
| TUM Klinikum rechts der Isar;Ambulanz für neurokognitive Erkrankungen | München | 81675 | Germany |
| Ospedale Cardinale Panico | Tricase (LE) | Apulia | 73039 | Italy |
| Umberto I Policlinico di Roma-Università di Roma La Sapienza | Rome | Lazio | 00185 | Italy |
| IRCCS Ospedale San Raffaele | Milan | Lombardy | 20132 | Italy |
| Fondazione Istituto Neurologico Mondino IRCCS | Pavia | Lombardy | 27100 | Italy |
| ProNeuro Centrum Medyczne | ?ory | 44-240 | Poland |
| Podlaskie Centrum Psychogeriatrii | Bia?ystok | 15-756 | Poland |
| NZOZ Vitamed | Bydgoszcz | 85-079 | Poland |
| NEURO-CARE Sp. z o.o. Sp. Komandytowa | Katowice | 40-749 | Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | 30-688 | Poland |
| Senior Sp. Z O.O. Poradnia Psychogeriatryczna | Sopot | 81-855 | Poland |
| EUROMEDIS Sp z o o | Szczecin | 70-111 | Poland |
| ETG Neuroscience Sp. z o.o. | Warsaw | 02-777 | Poland |
| NZOZ WCA | Wroc?aw | 53-659 | Poland |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Hospital General De Catalunya | Sant Cugat del Vallès | Barcelona | 8195 | Spain |
| Policlínica Guipuzcoa | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Hospital Quiron de Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Complejo Asistencial Universitario de Salamanca | Salamaca | Salamanca | 37007 | Spain |
| Fundacio ACE | Barcelona | 08028 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Victoria Eugenia | Seville | 41009 | Spain |
| Hospital Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Universitario Dr. Peset | Valencia | 46017 | Spain |
| Hospital Universitario la Fe | Valencia | 46026 | Spain |
| Surrey and Borders NHS Foundation Trust | Chertsey | KT16 9AU | United Kingdom |
| Scottish Brain Sciences | Edinburgh | EH12 9DQ | United Kingdom |
| RE:Cognition Health | London | W1G 8TA | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| Manchester Mental Health and Social Care Trust | Manchester | M13 9WL | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided