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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02553928
Other study ID # 14603A
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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-TRâ„¢ 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


Related Conditions & MeSH terms


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
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