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

Phase 4

Completed

• Conditions: Alzheimer Dementia (AD)
• Interventions: Drug: Memantine (once daily); Drug: Memantine (twice daily)

• Registration Number: NCT02553928
• Lead Sponsor: H. Lundbeck A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-16
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Study Start: 2015-10
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Results First Submitted: 2017-07-10
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-28
• Last Update Submitted: 2018-11-28
• Results First Posted: 2019-03-14
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Memantine (once daily)	Memantine (once daily)	Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally
Memantine (twice daily)	Memantine (twice daily)	Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally

Primary Outcome Measures

Name	Time	Method
Adverse Events	baseline to week 16 (end of study)	Number of patients who reported adverse events

Secondary Outcome Measures

Name	Time	Method
ADCS - CGIC Score at Week 12	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).

Trial Locations

Locations (6)

CN001; 🇨🇳 Beijing, China

CN006; 🇨🇳 Fujian, China

CN003; 🇨🇳 Zhejiang, China

CN004; 🇨🇳 Shandong, China

CN007; 🇨🇳 Xi'an, China

CN002; 🇨🇳 Tianjin, China