NCT00334906

Brief Summary

The purpose of this study is to characterize the progression of disease using volumetric MRI techniques and cognitive outcome measures in patients with moderate dementia of the Alzheimer's type treated with open-label memantine.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

January 7, 2008

Status Verified

January 1, 2008

Enrollment Period

2.3 years

First QC Date

June 6, 2006

Last Update Submit

January 3, 2008

Conditions

Alzheimer's Disease

Keywords

memantineAlzheimer's diseaseMRImoderate Alzheimer's disease

Outcome Measures

Primary Outcomes (2)

  • Efficacy

  • Total brain atrophy on MRI

Secondary Outcomes (2)

  • Other measures of brain atrophy on MRI, change from baseline in selected cognitive measures assessing multiple cognitive domains including memory, attention, motor-speed, auditory comprehension, and verbal fluency

  • Safety

Interventions

memantine HClDRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ambulatory male or female patients at least 50 years of age (females at least 2 years postmenopausal)
  • A diagnosis of probable AD \[according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA) criteria\] of moderate severity \[Mini-Mental State Examination score between 15 and 20, inclusive\]
  • On a stable dose of Food and Drug Administration (FDA)-approved acetylcholinesterase inhibitor

You may not qualify if:

  • Current Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) Axis I disorder other than AD
  • Previous imaging results not consistent with the diagnosis of AD
  • Modified Hachinski Ischemia Score greater than 4
  • Evidence of other neurologic disorders
  • Inability to participate in MRI testing
  • No clinically significant systemic disease
  • A known or suspected history of alcohol or drug abuse in the past 10 years
  • Taking excluded medication
  • Previous treatment with commercial memantine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forest Laboratories

Jersey City, New Jersey, 07311, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 6, 2006

First Posted

June 8, 2006

Study Start

July 1, 2005

Primary Completion

November 1, 2007

Last Updated

January 7, 2008

Record last verified: 2008-01

Locations

US(1)