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Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With Alzheimer

Primary Purpose

Alzheimer Dementia (AD)

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Memantine (once daily)
Memantine (twice daily)
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Dementia (AD)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinical visits during the study.
  • The patient has a diagnosis of probable AD consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
  • The patient has a Mini Mental State Examination (MMSE) score ≥ 5 and ≤ 18 at Screening visit
  • The dose of Memantine has been stable at 20 mg once a day for at least 3 month prior to screening

Exclusion Criteria:

  • The patient has one or more of the following conditions: Evidence and/or history of any clinically significant neurodegenerative disease or other serious neurological disorders other than Alzheimer's disease including, but not limited to, Lewy body dementia, Fronto-Temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, Multiple Sclerosis, major head trauma and primary or secondary cerebral neoplasm.
  • The patient has a modified Hachinski ischemia score greater than 4 at the screening visit.
  • The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than AD
  • The patient is currently receiving treatment with an unstable dose of acetyl cholinesterase inhibitor

Other protocol defined inclusion and exclusion criteria may apply

Sites / Locations

  • CN001
  • CN006
  • CN004
  • CN002
  • CN007
  • CN003

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Memantine (once daily)

Memantine (twice daily)

Arm Description

Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally

Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally

Outcomes

Primary Outcome Measures

Adverse Events
Number of patients who reported adverse events

Secondary Outcome Measures

ADCS - CGIC Score at Week 12
The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) is a semi-structured interview designed to assess clinically relevant changes in patients with Alzheimer's disease. Items in the ADCS-CGIC interview provide general information, and information about cognition, behaviour, social and daily functioning. Responses to ADCS-CGIC interview result in a global clinical judgement of severity (at baseline) and clinically relevant change at subsequent visits. Severity rated at baseline is only used for reference. The severity at baseline is rated on a 7-point Likert-type scale from 1(normal, not ill at all) to 7 (among the most extremely ill patients). The ADCS-CGIC relevant change is rated on a 7-point Likert-type scale from 1 (marked improvement) to 7 (marked worsening).

Full Information

First Posted
September 16, 2015
Last Updated
November 28, 2018
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02553928
Brief Title
Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With Alzheimer
Official Title
Interventional, Randomised, Double-blind, Study to Evaluate the Safety and Tolerability of Once Daily Versus Twice Daily Memantine Treatment in Patients With Dementia of Alzheimer's Type and MMSE Range 5 - 18
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared with 10 mg given twice daily in patients with dementia of Alzheimer's type and MMSE range 5-18.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Dementia (AD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memantine (once daily)
Arm Type
Experimental
Arm Description
Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally
Arm Title
Memantine (twice daily)
Arm Type
Experimental
Arm Description
Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally
Intervention Type
Drug
Intervention Name(s)
Memantine (once daily)
Other Intervention Name(s)
Lu 00-800, Ebixa ®, Ebix ®
Intervention Type
Drug
Intervention Name(s)
Memantine (twice daily)
Other Intervention Name(s)
Lu 00-800, Ebixa ®, Ebix ®
Primary Outcome Measure Information:
Title
Adverse Events
Description
Number of patients who reported adverse events
Time Frame
baseline to week 16 (end of study)
Secondary Outcome Measure Information:
Title
ADCS - CGIC Score at Week 12
Description
The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) is a semi-structured interview designed to assess clinically relevant changes in patients with Alzheimer's disease. Items in the ADCS-CGIC interview provide general information, and information about cognition, behaviour, social and daily functioning. Responses to ADCS-CGIC interview result in a global clinical judgement of severity (at baseline) and clinically relevant change at subsequent visits. Severity rated at baseline is only used for reference. The severity at baseline is rated on a 7-point Likert-type scale from 1(normal, not ill at all) to 7 (among the most extremely ill patients). The ADCS-CGIC relevant change is rated on a 7-point Likert-type scale from 1 (marked improvement) to 7 (marked worsening).
Time Frame
ADCS - CGIC score at Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinical visits during the study. The patient has a diagnosis of probable AD consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria. The patient has a Mini Mental State Examination (MMSE) score ≥ 5 and ≤ 18 at Screening visit The dose of Memantine has been stable at 20 mg once a day for at least 3 month prior to screening Exclusion Criteria: The patient has one or more of the following conditions: Evidence and/or history of any clinically significant neurodegenerative disease or other serious neurological disorders other than Alzheimer's disease including, but not limited to, Lewy body dementia, Fronto-Temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, Multiple Sclerosis, major head trauma and primary or secondary cerebral neoplasm. The patient has a modified Hachinski ischemia score greater than 4 at the screening visit. The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than AD The patient is currently receiving treatment with an unstable dose of acetyl cholinesterase inhibitor Other protocol defined inclusion and exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
CN001
City
Beijing
Country
China
Facility Name
CN006
City
Fujian
Country
China
Facility Name
CN004
City
Shandong
Country
China
Facility Name
CN002
City
Tianjin
Country
China
Facility Name
CN007
City
Xi'an
Country
China
Facility Name
CN003
City
Zhejiang
Country
China

12. IPD Sharing Statement

Learn more about this trial

Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With Alzheimer

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