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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Alzheimer Dementia (AD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Memantine (once daily)

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

Group Type EXPERIMENTAL

Memantine (once daily)

Intervention Type DRUG

Memantine (twice daily)

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

Group Type EXPERIMENTAL

Memantine (twice daily)

Intervention Type DRUG

Interventions

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Memantine (once daily)

Intervention Type DRUG

Memantine (twice daily)

Intervention Type DRUG

Other Intervention Names

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Lu 00-800 Ebixa ® Ebix ® Lu 00-800 Ebixa ® Ebix ®

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No