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OpenTrials
Completed

NCT Number: NCT02553928

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CN001, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Memantine (once daily)

Drug

Other names: Lu 00-800, Ebixa ®, Ebix ®

Memantine (twice daily)

Drug

Other names: Lu 00-800, Ebixa ®, Ebix ®

Primary outcomes

  1. Adverse Events

    Time frame: baseline to week 16 (end of study)

    Number of patients who reported adverse events

Secondary outcomes

  1. ADCS - CGIC Score at Week 12

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 18, 2015
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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