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

Lundbeck

Status and phase: Completed; Phase 4

Conditions: Alzheimer Dementia (AD)

Treatments: Drug: Memantine (twice daily); Drug: Memantine (once daily)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02553928

14603A

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

62 participants in 2 patient groups

Memantine (once daily)

Experimental group

Description:

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

Treatment:

Drug: Memantine (once daily)

Memantine (twice daily)

Experimental group

Description:

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

Treatment:

Drug: Memantine (twice daily)