Alzheimer Disease Clinical Trial
Official title:
Treatment of Periodontal Disease in Patients With Alzheimer's Disease: Randomized Controlled Trial
The main objective of this study is to evaluate the effect of periodontal therapy in in subjects with a clinical diagnosis of mild to moderate AD dementia.
This is a randomized, controlled study that will assess the effects of periodontal therapy in subjects with probable AD dementia according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. The study will enroll approximately 190 generally healthy male and female subjects ≥55 and ≤80 years of age. Enrolled subjects must have a documented diagnosis of mild to moderate AD dementia. The subject should not have other conditions or brain imaging abnormalities that can explain the symptoms of dementia. All subjects will be encouraged to have LPs (during screening, week 28 and week 52) in the absence of medical conditions that can increase the risk of the procedure in the opinion of the Investigator. Cerebrospinal fluid (CSF) and blood will be analyzed for measurements of biomarkers of AD and neuroinflammation, PiB-PET will be done for assessment of AD. A subset of sites will monitor subjects for clinical evidence of periodontitis at baseline, 28 and 52 weeks. The study will consist of 3 phases: a screening phase of up to 8 weeks, a treatment phase of up to 52 weeks, and a safety follow-up phase of 8 weeks. ;
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