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

Alzheimer Dementia (AD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553928
• Other study ID #: 14603A
• Status: Completed
• Phase: Phase 4
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: November 2018
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Dementia (AD)
• Alzheimer Disease
• Dementia

Intervention

Drug:
• Memantine (once daily)

• Memantine (twice daily)

Locations

Country	Name	City	State
China	CN001	Beijing
China	CN006	Fujian
China	CN004	Shandong
China	CN002	Tianjin
China	CN007	Xi'an
China	CN003	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of patients who reported adverse events	baseline to week 16 (end of study)
Secondary	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).	ADCS - CGIC score at Week 12