Memantine and Validation of a New Alzheimer's Disease Scale | NCT00804271

Studies
Memantine and Validation of a New Alzheimer's Disease Scale

NCT00804271

Sponsor

Merz Pharmaceuticals GmbH

Status

Completed

Last Update Posted

Feb 22, 2013Estimated

Enrollment

487Actual

Phase

Phase 3

Conditions

Alzheimer's Disease

Interventions

memantine

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT No. 2008-005144-16

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Dec 5, 2008

First Submission Date that Met QC Criteria

Dec 5, 2008

First Posted Date

Dec 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2013

Last Update Posted Date

Feb 22, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

487Actual

Label	Type	Description	Intervention Names
Memantine	Other		Drug: memantine

Name	Type	Description	Arm Group Labels	Other Names
memantine	Drug	memantine tablets, OD, 12 weeks	Memantine	Axura

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Validation of new scale regarding content, reliability and responsiveness for DAT symptoms		at post baseline visit

Secondary Outcomes

Measure	Description	Time Frame
Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD.		at a post baseline visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of Alzheimer's type.
Signed informed consent prior to the initiation of any study specific procedures.
Sight and hearing (a hearing aid is permitted) are sufficiently good to allow the undertaking of study-related procedures and psychometric tests.

Exclusion Criteria:

Evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
Intake of any medication that is contra-indicated in combination with memantine.
History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to ingredients of memantine or lactose.
Known or suspected history of alcoholism or drug abuse within the past 2 years.
Current or previous treatment with memantine or participation in an investigational study with memantine.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vjera Holthoff, MD	University Clinic Gustav Carus Dresden, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinic Gustav Carus		Dresden	Saxony	01307	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22492589	Result	Holthoff V, Ferris S, Gauthier S, Ihl R, Robert P, Winblad B, Sternberg K, Tennigkeit F; ROSA Study Group. Memantine effects measured with the Relevant Outcome Scale for Alzheimer's disease in an open-label, single-arm, multicenter clinical study. Int J Geriatr Psychiatry. 2013 Feb;28(2):164-72. doi: 10.1002/gps.3805. Epub 2012 Apr 11.
21914212

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D000547	Amantadine
D000218	Adamantane
D001952	Bridged-Ring Compounds
D006844	Hydrocarbons, Cyclic