Study of the Effects of Current Drug Treatments on Levels... | NCT00104442

Studies
Study of the Effects of Current Drug Treatments on Levels of Certain Brain Chemicals in Alzheimer's Disease

NCT00104442

Sponsor

Novartis

Status

Completed

Last Update Posted

Dec 21, 2007Estimated

Enrollment

Phase

Phase 4

Conditions

Alzheimer's Disease

Interventions

Rivastigmine

Countries

United States

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

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2003

Primary Completion Date

Not provided

Completion Date

Apr 2006Actual

First Submitted Date

Feb 28, 2005

First Submission Date that Met QC Criteria

Feb 28, 2005

First Posted Date

Mar 1, 2005Estimated

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

Dec 17, 2007

Last Update Posted Date

Dec 21, 2007Estimated

Description Module

Brief Summary

Alzheimer's disease is a medical illness that damages the brain and causes problems with memory, mood and behavior. A substance called acetylcholine (ACh), which is naturally produced in the body, plays an important role in the normal functioning of the brain. In subjects with Alzheimer's disease, the level of ACh is greatly reduced. Currently, there are three commonly prescribed drugs used for treating the symptoms of Alzheimer's disease by helping to maintain the level of ACh in the brain. This study will evaluate how much each of these drugs changes the levels of certain brain chemicals that are known to, or may play an important role in, Alzheimer's disease and its symptoms.

Detailed Description

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Rivastigmine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in specific brain enzyme activity from baseline to week 13

Secondary Outcomes

Measure	Description	Time Frame
Correlate changes in specific brain enzyme activity at week 13 to cognition and behavior
Changes in levels of protein biomarkers in Alzheimer's disease and neurodegeneration from baseline to week 13

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of mild to moderate Alzheimer's disease
Must be able to swallow capsule/tablet
Must have a caregiver who is available to attend all study visits

Exclusion Criteria:

Digestive problems related to peptic ulcer
Experienced a heart attack or stroke in the last 6 months
Serious/unstable asthma or severe pulmonary (lung) disease
On current treatment with a blood thinner

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Pharmaceuticals		East Hanover	New Jersey	07936	United States

Label	URL
Click here for information about study sites in your area	View source

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease
D008569	Memory Disorders
D003704	Dementia
D001519	Behavior

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068836	Rivastigmine

Ancestor Terms

ID	Term
D048448	Phenylcarbamates
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided