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Tests treatment safety and results for Alzheimer's Disease
Official title A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)
ClinicalTrials.gov ID: NCT07234942
What this study is testing
What is RO7812653?
RO7812653 is an investigational medicine, being studied as a potential treatment for alzheimer's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 75
You may be able to join if
- Probable AD dementia (consistent with National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria for probable AD...
- Willingness and ability to complete all aspects of the study. The participant should be capable of completing assessments either alone or with the...
- 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...
- If the participant is receiving symptomatic AD medications, a stable dosing regimen for at least 8 weeks prior to screening and until randomization...
You likely can't join if
- 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.'
- Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological medical conditions which are not stable and...
See the full eligibility criteria
- 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...
- 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).
- If the participant is receiving symptomatic AD medications, a stable dosing regimen for at least 8 weeks prior to screening and until randomization is required.
- Agreement not to participate in other research studies for the duration of this study.
- 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.'
- Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological medical conditions which are not stable and adequately controlled or which in the opinion of the investigator could...
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
- Amsterdam, North Holland, Netherlands
- Barcelona, Spain
- Córdoba, Spain
- Mlndal, Sweden
- Solna, Sweden
- London, Greater London, United Kingdom
- Southampton, Hampshire, United Kingdom
- Glasgow, Strathclyde, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada; Amsterdam, North Holland, Netherlands; Barcelona, Spain; Córdoba, Spain; Mlndal, Sweden; Solna, Sweden and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.