NCT00862940

Brief Summary

Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Previous studies have shown that memantine helps to treat the symptoms of Alzheimer's Disease (AD). In AD, the rate of brain tissue loss, or atrophy, is faster than in normal aging and this seems to go hand in hand with some of the symptoms of the disease. This suggests that memantine treatment in AD could provide both symptomatic improvement and neuro-protective effects. The purpose of this study was to show whether memantine, in addition to providing symptomatic benefits, can slow the rate of brain atrophy as assessed using magnetic resonance imaging (MRI) technology.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
277

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_4

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

September 1, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

June 3, 2011

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

3.4 years

First QC Date

March 16, 2009

Results QC Date

November 23, 2010

Last Update Submit

August 29, 2012

Conditions

Alzheimer's Disease

Keywords

MemantineNeuroimagingMRIBrain atrophy

Outcome Measures

Primary Outcomes (1)

  • Total Brain Atrophy Rate Estimated Using Brain Boundary Shift Integral (BBSI)

    Measures direct changes in total brain volume per visit interval (screening to Week 4, 42, or 52 or from Week 4 to Week 42 or 52)

    Baseline to 1 year

Secondary Outcomes (3)

  • Changes in Total Hippocampal Volume (HCV)

    Baseline to 1 year

  • Cognitive and Behavioural Outcomes: Controlled Oral Word Association Test (COWAT) Total Score

    Baseline to 1 year

  • Cognitive and Behavioural Outcomes: Mini Mental State Examination (MMSE) Total Score

    Baseline to 1 year

Study Arms (2)

Memantine

EXPERIMENTAL
Drug: Memantine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MemantineDRUG

10 mg tablets twice daily

Also known as: Ebixa®
Memantine
PlaceboDRUG

Tablets twice daily

Placebo

Eligibility Criteria

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

You may qualify if:

  • Outpatients at least 50 years of age with a current diagnosis of probable AD of moderate severity (MMSE score between 12 and 20, inclusive) consistent with NINCDS-ADRDA criteria and MRI scans
  • Patients must have had a knowledgeable and reliable caregiver to accompany them to all clinic visits during the study
  • Patients were either on or off existing acetylcholinesterase inhibitor (AChEI) treatment provided that the treatment had been initiated \>6 months prior to screening, had stabilised with respect to dose for \>3 months, and remained fixed during the entire study. AChEI treatment could not be initiated or modified during the study

You may not qualify if:

  • The patient had evidence of clinically significant active disease (including recent myocardial infarction and uncompensated congestive heart failure \[NYHA II-IV\])
  • The patient had evidence of any clinically significant neurodegenerative disease or neurological disorder other than AD
  • The patient was contraindicated for MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wilkinson D, Fox NC, Barkhof F, Phul R, Lemming O, Scheltens P. Memantine and brain atrophy in Alzheimer's disease: a 1-year randomized controlled trial. J Alzheimers Dis. 2012;29(2):459-69. doi: 10.3233/JAD-2011-111616.

    PMID: 22269160RESULT

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

Results Point of Contact

Title
H. Lundbeck A/S
Organization
H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
+45 3630 1311

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

September 1, 2005

Primary Completion

February 1, 2009

Study Completion

April 1, 2009

Last Updated

September 3, 2012

Results First Posted

June 3, 2011

Record last verified: 2012-08