Memantine Treatment in Alzheimer's Disease Patients

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

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

Study Overview

• Status: Unknown
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: Memantine Hydrochloride

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
• Enrollment (Anticipated): 222
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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 Names: Memantine
OTHER: 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 Names: Memantine
OTHER: 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 Names: Memantine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADAS-cog change	Alzheimer's Disease Co-operative Study Alzheimer's Disease Assessment Scale - cognitive section is the cognitive evaluation scale	ADAD-cog Change from baseline to 24 weeks

Collaborators and Investigators

• Sponsor: Wei Cuibai

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 15, 2017
• Primary Completion (ANTICIPATED): September 30, 2018
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (ACTUAL): May 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Alzheimer Disease Memantine
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Memantine
• Other Study ID Numbers: 17237T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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