Memantine Treatment in Alzheimer's Disease Patients

NCT03168997 | Unknown Phase 4

• 1 other identifier: 17237T
• Study Type: interventional
• Target: 222
• Locations: 0 countries
• Sites: N/A

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

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease Memantine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Mild AD

OTHER

Memantine Hydrochloride 20mg tablet per day by mouth on mild AD

Drug: Memantine Hydrochloride

Moderate AD

OTHER

Memantine Hydrochloride 20mg tablet per day by mouth on moderate AD

Drug: Memantine Hydrochloride

Severe AD

OTHER

Memantine Hydrochloride 20mg tablet per day by mouth on severe AD

Drug: Memantine Hydrochloride

Interventions

Memantine Hydrochloride DRUG

Memantine Hydrochloride treatment according to clinical routine treatment

Also known as: Memantine

Mild AD; Moderate AD; Severe AD

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wei Cuibai: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, PhD.

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 30, 2017
• Study Start: July 15, 2017
• Primary Completion: September 30, 2018
• Study Completion: December 31, 2018
• Last Updated: May 30, 2017

Record last verified: 2017-05