Clinical trial NCT06402838: A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter, Parallel-Group Study to Investigate the Safety, Tolerability, and the Effect of RO7269162 on Amyloid and Non-Amyloid Disease-Related Biomarkers Following Daily Oral Administration in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2024-05-07
Enrollment: 245
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: up to week 72
measure: Change from baseline in brain amyloid load, as measured by amyloid positron emission tomography ( PET) scan
timeFrame: Baseline to Week 72
Secondary outcomes:
measure: Change from baseline in Aβ37 in cerebrospinal fluid (CSF)
timeFrame: Baseline to Week 72
measure: Change from baseline in Aβ38 in CSF
timeFrame: Baseline to Week 72
measure: Change from baseline in Aβ40 in CSF
timeFrame: Baseline to Week 72
measure: Change from baseline in Aβ42 in CSF
timeFrame: Baseline to Week 72
measure: Change from baseline in Aβ40 in plasma
timeFrame: Baseline to Week 72
measure: Change from baseline in Aβ42 in plasma
timeFrame: Baseline to Week 72
measure: Plasma concentrations of RO7269162
timeFrame: Baseline to Week 72
measure: CSF concentrations of RO7269162
timeFrame: Baseline to Week 72
Other outcomes:
measure: Change from baseline in p-tau 217 in plasma
timeFrame: Baseline to Week 72
Locations:
city: Santiago
country: Chile
facility: Centro de Investigación Clínica UC-CICUC
city: Santiago
country: Chile
facility: Hospital Clinico Univ de Chile
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital Skejby
city: Koebenhavn Oe
country: Denmark
facility: Rigshospitalet, Hukommelsesklinikken
city: Bron cedex
country: France
facility: Groupement Hospitalier Est - Hôpital Neurologique
city: Lille
country: France
facility: Hopital B Roger Salengro
city: Marseille Cedex 5
country: France
facility: Hôpital de la Timone
city: Paris
country: France
facility: Hôpital Lariboisière
city: Rouen
country: France
facility: CHU de Rouen Hopital
city: St Herblain
country: France
facility: Hop Guillaume Et Rene Laennec
city: Strasbourg
country: France
facility: Hôpital Robertsau
city: Toulouse
country: France
facility: Gerontopole
city: Berlin
country: Germany
facility: Ambulates Gesundheitszentrum der Charité GmbH
city: Berlin
country: Germany
facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
city: Böblingen
country: Germany
facility: Studienzentrum Dr. Bischof GmbH
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Roma
country: Italy
facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza
state: Lazio
city: Brescia
country: Italy
facility: Asst Degli Spedali Civili Di Brescia
state: Lombardia
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Mondino IRCCS
state: Lombardia
city: Tricase (LE)
country: Italy
facility: Ospedale Cardinale Panico
state: Puglia
city: Perugia
country: Italy
facility: AO di Perugia - Ospedale S. Maria della Misericordia
state: Umbria
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: ?ory
country: Poland
facility: ProNeuro Centrum Medyczne
city: Bia?ystok
country: Poland
facility: Podlaskie Centrum Psychogeriatrii
city: Bydgoszcz
country: Poland
facility: NZOZ Vitamed
city: Katowice
country: Poland
facility: NEURO-CARE Sp. z o.o. Sp. Komandytowa
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Sopot
country: Poland
facility: Senior Sp. Z O.O. Poradnia Psychogeriatryczna
city: Szczecin
country: Poland
facility: EUROMEDIS Sp z o o
city: Warszawa
country: Poland
facility: ETG Neuroscience Sp. z o.o.
city: Wroc?aw
country: Poland
facility: NZOZ WCA
city: Sant Cugat del Valles
country: Spain
facility: Hospital General De Catalunya
state: Barcelona
city: SANtander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Donostia-san Sebastian
country: Spain
facility: Policlínica Guipuzcoa
state: Guipuzcoa
city: Pozuelo de Alarcón
country: Spain
facility: Hospital Quiron de Madrid
state: Madrid
city: Salamaca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca
state: Salamanca
city: Barcelona
country: Spain
facility: Fundacio ACE
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Sevilla
country: Spain
facility: Hospital Victoria Eugenia
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Valencia
country: Spain
facility: Hospital Universitario la Fe
city: Birmingham
country: United Kingdom
facility: Re:Cognition Health Birmingham
city: Chertsey
country: United Kingdom
facility: Surrey and Borders NHS Foundation Trust
city: Edinburgh
country: United Kingdom
facility: Scottish Brain Sciences
city: London
country: United Kingdom
facility: RE:Cognition Health
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Manchester
country: United Kingdom
facility: Manchester Mental Health and Social Care Trust
city: Newcastle
country: United Kingdom
facility: Campus for Ageing & Vitality
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: