Back to resultsMemantine Treatment in Alzheimer's Disease Patients
Primary Purpose
Alzheimer Disease
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Memantine Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer Disease Memantine
Eligibility Criteria
Inclusion Criteria:
- Probable AD based on the diagnosis criteria of NIA-AA guideline (the U.S. National Institute on Aging and Alzheimer's Association guideline, McKhann et al, 2011[8];
- Male or female, 50 years and older ;
- All inpatients or outpatients recruited into this study must meet MMSE score ≤24 points, patients with MMSE score as 21-24 points will be enrolled into mild group, patients with MMSE score as 10-20 points will be enrolled into moderate group, patients with MMSE score less than 10 points will be enrolled into severe group.
- Have a reliable caregiver who can accompany the patient to the site to complete the required study procedures;
- Provide the informed consent.
Exclusion Criteria:
- Patients with disturbance of consciousness of any causes;
- Patients with severe aphasia or physical disability who were unable to complete neuropsychological examination;
- Patients with mental illness;
- Patients with a history of alcoholism and drug addiction, or traumatic brain injury, epilepsy, encephalitis, normal-pressure hydrocephalus and other neurological disorders causing cognitive impairment;
- Patients with systemic diseases causing dementia (e.g. liver and kidney insufficiency, endocrine disorders, vitamin deficiency);
- Patients with a history of ischemic or hemorrhagic cerebrovascular diseases, and vascular diseases (stroke foci) as confirmed by imaging examination;
- Subjects who are unwilling or unable to abide by the study requirement.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Mild AD
Moderate AD
Severe AD
Arm Description
Memantine Hydrochloride 20mg tablet per day by mouth on mild AD
Memantine Hydrochloride 20mg tablet per day by mouth on moderate AD
Memantine Hydrochloride 20mg tablet per day by mouth on severe AD
Outcomes
Primary Outcome Measures
ADAS-cog change
Alzheimer's Disease Co-operative Study Alzheimer's Disease Assessment Scale - cognitive section is the cognitive evaluation scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03168997
Brief Title
Memantine Treatment in Alzheimer's Disease Patients
Official Title
Memantine Treatment in Alzheimer's Disease Patients Stratified With Behavioral and Psychological Symptoms of Dementia (BPSD) Symptoms and Cognitive Severity: A Multi-center, Open-label, Parallel-group and Prospective Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2017 (Anticipated)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wei Cuibai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The aim of this study is to investigate whether there will be any efficacy difference of Memantine treatment in different cognitive severity AD patients stratified with BPSD
Detailed Description
Planed to enroll a total of 222 patients with mild, moderate or severe AD treated with Memantine in 2017-2018 from 15 centers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer Disease Memantine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
222 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mild AD
Arm Type
Other
Arm Description
Memantine Hydrochloride 20mg tablet per day by mouth on mild AD
Arm Title
Moderate AD
Arm Type
Other
Arm Description
Memantine Hydrochloride 20mg tablet per day by mouth on moderate AD
Arm Title
Severe AD
Arm Type
Other
Arm Description
Memantine Hydrochloride 20mg tablet per day by mouth on severe AD
Intervention Type
Drug
Intervention Name(s)
Memantine Hydrochloride
Other Intervention Name(s)
Memantine
Intervention Description
Memantine Hydrochloride treatment according to clinical routine treatment
Primary Outcome Measure Information:
Title
ADAS-cog change
Description
Alzheimer's Disease Co-operative Study Alzheimer's Disease Assessment Scale - cognitive section is the cognitive evaluation scale
Time Frame
ADAD-cog Change from baseline to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Probable AD based on the diagnosis criteria of NIA-AA guideline (the U.S. National Institute on Aging and Alzheimer's Association guideline, McKhann et al, 2011[8];
Male or female, 50 years and older ;
All inpatients or outpatients recruited into this study must meet MMSE score ≤24 points, patients with MMSE score as 21-24 points will be enrolled into mild group, patients with MMSE score as 10-20 points will be enrolled into moderate group, patients with MMSE score less than 10 points will be enrolled into severe group.
Have a reliable caregiver who can accompany the patient to the site to complete the required study procedures;
Provide the informed consent.
Exclusion Criteria:
Patients with disturbance of consciousness of any causes;
Patients with severe aphasia or physical disability who were unable to complete neuropsychological examination;
Patients with mental illness;
Patients with a history of alcoholism and drug addiction, or traumatic brain injury, epilepsy, encephalitis, normal-pressure hydrocephalus and other neurological disorders causing cognitive impairment;
Patients with systemic diseases causing dementia (e.g. liver and kidney insufficiency, endocrine disorders, vitamin deficiency);
Patients with a history of ischemic or hemorrhagic cerebrovascular diseases, and vascular diseases (stroke foci) as confirmed by imaging examination;
Subjects who are unwilling or unable to abide by the study requirement.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Memantine Treatment in Alzheimer's Disease Patients
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