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)

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06402838
• Other study ID #: BP44745
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2, 2024
• Est. completion date: May 19, 2027

Study information

• Verified date: May 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: BP44745 https://forpatients.roche.com
• Phone: 888-662-6728
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 245
• Est. completion date: May 19, 2027
• Est. primary completion date: May 19, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Prodromal Symptoms

Intervention

Drug:
• RO7269162
Participants will receive daily doses (one of three dose levels) of RO7269162 for up to 72 weeks.
• Placebo
Participants will receive daily doses of placebo for up to 72 weeks.

Locations

Country	Name	City	State
Chile	Centro de Investigación Clínica UC-CICUC	Santiago
Denmark	Aarhus Universitetshospital Skejby; Neurologisk Forskning	Aarhus N
France	Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)	Bron cedex
France	Hôpital Lariboisière	Paris
France	Hôpital Robertsau; HDJ Recherche	Strasbourg
France	Gerontopole; Centre de Recherche clinique	Toulouse
Italy	IRCCS Ospedale San Raffaele; U.O. di Neurologia	Milano	Lombardia
Italy	Umberto I Policlinico di Roma-Università di Roma La Sapienza	Roma	Lazio
Italy	Ospedale Cardinale Panico; Dip.Ricerca Clinica in Neurologia ? UO Malattie Neurodegenerative	Tricase (LE)	Puglia
Korea, Republic of	Ajou University Medical Center	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Poland	Podlaskie Centrum Psychogeriatrii	Bia?ystok
Poland	NZOZ Vitamed	Bydgoszcz
Poland	Szpital Uniwersytecki w Krakowie; Oddzia? Kliniczny Neurologii	Kraków
Poland	Senior Sp. Z O.O. Poradnia Psychogeriatryczna	Sopot
Poland	ETG Neuroscience Sp. z o.o.	Warszawa
Poland	NZOZ WCA	Wroc?aw
Spain	Fundacio ACE	Barcelona
Spain	Policlínica Guipuzcoa; Servicio de Neurología	Donostia-san Sebastian	Guipuzcoa
Spain	Hospital Universitario 12 de Octubre; Servicio de Neurologia	Madrid
Spain	Hospital Quiron de Madrid; Servicio de Neurologia	Pozuelo de Alarcon	Madrid
Spain	Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría	Salamanca
Spain	Hospital General De Catalunya; Servicio de Neurologia	Sant Cugat del Valles	Barcelona
Spain	Hospital Universitario Marques de Valdecilla; Servicio de Neurología	SANtander	Cantabria
Spain	Hospital Virgen del Rocío; Servicio de Neurología	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Chile,  Denmark,  France,  Italy,  Korea, Republic of,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in p-tau 217 in plasma		Baseline to Week 72
Primary	Incidence of adverse events (AEs)		up to week 72
Primary	Change from baseline in brain amyloid load, as measured by amyloid positron emission tomography ( PET) scan		Baseline to Week 72
Secondary	Change from baseline in Aß37 in cerebrospinal fluid (CSF)		Baseline to Week 72
Secondary	Change from baseline in Aß38 in CSF		Baseline to Week 72
Secondary	Change from baseline in Aß40 in CSF		Baseline to Week 72
Secondary	Change from baseline in Aß42 in CSF		Baseline to Week 72
Secondary	Change from baseline in Aß40 in plasma		Baseline to Week 72
Secondary	Change from baseline in Aß42 in plasma		Baseline to Week 72
Secondary	Plasma concentrations of RO7269162		Baseline to Week 72
Secondary	CSF concentrations of RO7269162		Baseline to Week 72