Efficacy and Safety of Rivastigmine in Patients With Mild... | NCT00134953

Studies
Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

NCT00134953

Sponsor

Novartis

Status

Terminated

Last Update Posted

Dec 17, 2007Estimated

Enrollment

Phase

Phase 3

Conditions

Cognitive Symptoms

Interventions

Rivastigmine

Countries

Not provided

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

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The Principal Investigator left the clinic and there was no one who could take over this study.

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Not provided

Completion Date

May 2004Actual

First Submitted Date

Aug 23, 2005

First Submission Date that Met QC Criteria

Aug 23, 2005

First Posted Date

Aug 25, 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 14, 2007

Last Update Posted Date

Dec 17, 2007Estimated

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

Name	Type	Description	Arm Group Labels	Other Names
Rivastigmine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment

Secondary Outcomes

Measure	Description	Time Frame
Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females who are one year post-menopausal or without childbearing potential
Between the ages of 50 and 85 years old
Mild cognitive impairment confirmed by Mini Mental State Examination (MMSE) score between 23 and 27
Cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver, according to the investigator's judgement

Exclusion Criteria:

A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances or secondary dementia
A current diagnosis of epilepsy or depression, or any other diagnosis that may interfere with the patient's response to study medication
An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations

Other protocol-defined exclusion criteria may apply.

Accepts Healthy Volunteers

Not provided

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

Name	Affiliation	Role
Novartis Pharmaceuticals Corporation	Novartis Pharmaceuticals	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D019954	Neurobehavioral Manifestations
D060825	Cognitive Dysfunction
D000544	Alzheimer Disease
D003704	Dementia

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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