Health Trials

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)

ConditionAlzheimer's Disease
Trial statusActive, not recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50-75
SponsorHoffmann-La Roche

About this trial

This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Probable AD dementia (consistent with National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria for probable AD dementia) [McKhann et al 2011] or Mild Cognitive Impairment (MCI) due to AD (consistent with the NIA-AA core clinical criteria for mild cognitive impairment due to AD) [Albert et al 2011]).

Willingness and ability to complete all aspects of the study. The participant should be capable of completing assessments either alone or with the help of the study partner.

Fluency in the language of the tests used at the study site.

Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted).

Disqualifiers

Any medical history or evidence of a condition other than AD that may affect cognition.

Presence of any significant cerebral abnormalities that would contraindicate lumbar puncture, as assessed on MRI

Any other significant cerebral abnormalities that the Investigator considers clinically significant

History of schizophrenia, schizoaffective disorder, major depression or bipolar disorder.'

Trial design

Design model

Parallel

Treatments tested in this trial

  • RO7812653

    Drug

    Participants will receive RO7812653 as per the schedule in the protocol

  • Placebo

    Drug

    Participants will receive placebo as per the schedule in the protocol

Treatment groups

6 Participants
are divided into 2 treatment groups
Group A: RO7812653Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants with Adverse Events

Time frame
Up to approximately 40 weeks
2

Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores

C-SSRS measures 4 constructs as follows: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories. Numeric ratings are provided for intensity of ideation (if present), from 1 to 5, with 1 being the least severe and 5 being the most severe.

Time frame
Up to approximately 40 weeks

Secondary outcomes

1

Plasma Concentration of RO7812653

Time frame
Up to approximately 40 weeks
2

Cerebral Spinal Fluid (CSF) Concentration of RO7812653

Time frame
Up to approximately 40 weeks
3

Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7812653

Time frame
Up to approximately 40 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: