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Trial record 1 of 1884 for:    "Alzheimer disease familial"
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Memantine Treatment in Alzheimer's Disease Patients

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ClinicalTrials.gov Identifier: NCT03168997
Recruitment Status : Not yet recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Wei Cuibai, Xuanwu Hospital, Beijing

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

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Memantine Hydrochloride Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 15, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 31, 2018


Arm Intervention/treatment
Mild AD
Memantine Hydrochloride 20mg tablet per day by mouth on mild AD
Drug: Memantine Hydrochloride
Memantine Hydrochloride treatment according to clinical routine treatment
Other Name: Memantine

Moderate AD
Memantine Hydrochloride 20mg tablet per day by mouth on moderate AD
Drug: Memantine Hydrochloride
Memantine Hydrochloride treatment according to clinical routine treatment
Other Name: Memantine

Severe AD
Memantine Hydrochloride 20mg tablet per day by mouth on severe AD
Drug: Memantine Hydrochloride
Memantine Hydrochloride treatment according to clinical routine treatment
Other Name: Memantine




Primary Outcome Measures :
  1. ADAS-cog change [ Time Frame: ADAD-cog Change from baseline to 24 weeks ]
    Alzheimer's Disease Co-operative Study Alzheimer's Disease Assessment Scale - cognitive section is the cognitive evaluation scale



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Responsible Party: Wei Cuibai, Professor, MD, PhD., Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03168997     History of Changes
Other Study ID Numbers: 17237T
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Wei Cuibai, Xuanwu Hospital, Beijing:
Alzheimer Disease Memantine

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents