Treatment of Periodontal Disease in Patients With Alzheimer's Disease

Launched by UNION HOSPITAL, TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Dec 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of dental treatment for gum disease, known as periodontal therapy, in people who have mild to moderate Alzheimer's disease (AD) dementia. The goal is to see if treating gum disease can help improve the health and well-being of these patients.

To be eligible for the study, participants should have a primary school education or higher and a confirmed diagnosis of Alzheimer's dementia, backed by brain imaging. They need to have a stable medical condition and a caregiver who can help supervise the treatment and monitor their progress. Participants will be carefully screened to ensure they do not have other types of dementia or serious health issues that could interfere with the study. Since the trial has not started recruiting yet, interested individuals should stay tuned for more information on how to participate. Overall, this trial aims to explore a new approach to supporting the health of those living with Alzheimer’s disease through improved dental care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject has primary school education or above.
• • Subject has probable AD dementia according to the NIA-AA criteria.
• • Subject has brain MRI scan consistent with the diagnosis of AD performed during the screening period. Computed Tomography scan can be used only if the subject has an absolute contraindication for MRI.
• • Subject has a Modified Hachinski score ≤4 at screening.
• • Subject has an MMSE score ≥15 at screening.
• • Subjects with background symptomatic therapy with acetylcholine esterase inhibitors, and/or memantine, are allowed as long as the dose has been stable for 90 days prior to screening and no changes are planned during the study.
• • Subject has a primary caregiver willing to accept responsibility for supervising the treatment (e.g., administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.
• • Subject has body mass index \<38 kg/m2 at Screening
• Exclusion Criteria:
• • Subject has imaging consistent with a dementia diagnosis other than AD.
• • Subject has had an increase or restoration of cognition based on medical history.
• • Subject with history or current evidence of major psychiatric illness such as schizophrenia, bipolar disorder, or major depressive disorder that may interfere with the patient's ability to perform the study and all assessments. NOTE: Mild depression or depressive mood arising in the context of AD are not criteria for exclusion. The use of anti-depressants or the use of anti epileptic medication for non seizure-related treatment is allowed if the dose has remained stable for at least 60 days prior to enrollment.
• • Subject is fitted with pacemakers (except for new compatible products), large ferromagnetic implants, or implanted electronic devices such as cochlear implants, magnetic metal drug infusion pumps, nerve stimulators, diaphragmatic stimulators and injection pumps, physiological stimulators, and cardiac mechanical valves.
• • Subject has magnetic metal foreign body or prosthesis in eye, magnetic metal joint or ferromagnetic foreign body in body.
• • Subject has epilepsy or claustrophobia.
• • Subject had received antibiotics or periodontal treatment within the last 6 months.
• • Subject had taken aspirin, warfarin and other anticoagulant drugs in the last 6 months.
• * Subject has any of the following laboratory findings at screening:
• • 1. Coagulation disorders.
• • 2. Hemoglobin ≤10 g/dl.
• • 3. Poorly controlled diabetes as defined by hemoglobin A1C (HbA1C) \>8.
• • 4. Positive blood screen for Human Immunodeficiency Virus (HIV 1 and 2), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus antibodies (HCV-Ab) at Screening.