Study of Memantine in Assessment of Selected Measures of Volumetric Magnetic Resonance Imaging (MRI) and Cognition in Moderate AD (Alzheimer's Disease)

An Open-Label Exploratory Study With Memantine: Assessment of Selected Measures of Volumetric MRI and Cognition in Patients With Moderate Dementia of the Alzheimer's Type

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00334906

Enrollment

Registered

2006-06-08

Start date

2005-07-31

Completion date

Unknown

Last updated

2008-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

memantine, Alzheimer's disease, MRI, moderate Alzheimer's disease

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.

Interventions

DRUGmemantine HCl

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Efficacy	—
Total brain atrophy on MRI	—

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026