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
Memantine Treatment in Alzheimer's Disease Patients
Sponsors
Source
Xuanwu Hospital, Beijing
Oversight Info
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Is Us Export
No
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.
Overall Status
Unknown status
Start Date
2017-07-15
Completion Date
2018-12-31
Primary Completion Date
2018-09-30
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
ADAS-cog change |
ADAD-cog Change from baseline to 24 weeks |
Enrollment
222
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
Memantine Hydrochloride treatment according to clinical routine treatment
Arm Group Label
Mild AD
Moderate AD
Severe AD
Other Name
Memantine
Eligibility
Criteria
Inclusion Criteria:
1. 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];
2. Male or female, 50 years and older ;
3. 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.
4. Have a reliable caregiver who can accompany the patient to the site to complete the
required study procedures;
5. Provide the informed consent.
Exclusion Criteria:
1. Patients with disturbance of consciousness of any causes;
2. Patients with severe aphasia or physical disability who were unable to complete
neuropsychological examination;
3. Patients with mental illness;
4. 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;
5. Patients with systemic diseases causing dementia (e.g. liver and kidney insufficiency,
endocrine disorders, vitamin deficiency);
6. Patients with a history of ischemic or hemorrhagic cerebrovascular diseases, and
vascular diseases (stroke foci) as confirmed by imaging examination;
7. Subjects who are unwilling or unable to abide by the study requirement.
Gender
All
Minimum Age
50 Years
Maximum Age
N/A
Healthy Volunteers
No
Verification Date
2017-05-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor-Investigator
Investigator Affiliation
Xuanwu Hospital, Beijing
Investigator Full Name
Wei Cuibai
Investigator Title
Professor, MD, PhD.
Keyword
Has Expanded Access
No
Condition Browse
Number Of Arms
3
Intervention Browse
Mesh Term
Memantine
Arm Group
Arm Group Label
Mild AD
Arm Group Type
Other
Description
Memantine Hydrochloride 20mg tablet per day by mouth on mild AD
Arm Group Label
Moderate AD
Arm Group Type
Other
Description
Memantine Hydrochloride 20mg tablet per day by mouth on moderate AD
Arm Group Label
Severe AD
Arm Group Type
Other
Description
Memantine Hydrochloride 20mg tablet per day by mouth on severe AD
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
Undecided
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Study First Submitted
May 16, 2017
Study First Submitted Qc
May 25, 2017
Study First Posted
May 30, 2017
Last Update Submitted
May 25, 2017
Last Update Submitted Qc
May 25, 2017
Last Update Posted
May 30, 2017
Last Known Status
Not yet recruiting
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.