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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
periodontal cleaning
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)
Mean change in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) from baseline to the end of treatment period. ADAS-Cog 11 measures cognitive functions and non-cognitive functions such as mood and behavior. Total scores range from 0-70, with higher scores (≥ 18) indicating greater cognitive impairment. ADAS-Cog 11 score increases by 2-4 points per year on average in subjects with mild to moderate Alzheimer's Disease. A treatment period of 52 weeks was selected to allow sufficient time to demonstrate at least 2.5 points difference between active treatment and placebo on ADAS-Cog 11 at the end of the treatment period.
Time frame: 52 weeks
ADCS-ADL
Change in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)
Time frame: 52 weeks
MMSE
Change in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living Change in Mini-Mental State Examination (MMSE).
Time frame: 52 weeks
MoCA
Change in Montreal Cognitive Assessment Scale
Time frame: 52 weeks
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