Treatment of Periodontal Disease in Patients With Alzheimer's Disease

NCT05183321 | Not Yet Recruiting

• 1 other identifier: KQCLLAD001
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Periodontitis; Alzheimer Disease; Dementia

Outcome Measures

Primary Outcomes (2)

• 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.

  52 weeks

• ADCS-ADL

  Change in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)

  52 weeks

Secondary Outcomes (2)

• MMSE

  52 weeks

• MoCA

  52 weeks

Other Outcomes (6)

• PiB-PET

  52 weeks

• Tau-PET

  52 weeks

• Tau levels in cerebrospinal fluid

  52 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Group will not receive treatment: periodontal therapy

Periodontal therapy

EXPERIMENTAL

Group will receive treatment: periodontal therapy

Procedure: periodontal therapy

Interventions

periodontal therapy PROCEDURE

periodontal cleaning

Periodontal therapy

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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:
• Coagulation disorders.
• Hemoglobin ≤10 g/dl.
• Poorly controlled diabetes as defined by hemoglobin A1C (HbA1C) \>8.
• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

MeSH Terms

Conditions

Periodontitis; Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lili Chen

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Lili Chen, PhD

CONTACT

0086-027-85726480; lily-c1030@163.com

Mengru Xie

CONTACT

0086-027-85726480; hbxiemengru@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: January 10, 2022
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 13, 2024

Record last verified: 2024-04