Study Evaluating SRA-333 in Mild to Moderate Alzheimer's... | NCT00151333

Studies
Study Evaluating SRA-333 in Mild to Moderate Alzheimer's Disease (AD)

NCT00151333

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Sep 4, 2009Estimated

Enrollment

Phase

Phase 2

Conditions

Alzheimer's Disease

Interventions

SRA-333

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

Sep 2009

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

Feb 2005

Primary Completion Date

Apr 2005Actual

Completion Date

Apr 2005Actual

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 6, 2005

First Posted Date

Sep 8, 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

Sep 3, 2009

Last Update Posted Date

Sep 4, 2009Estimated

Description Module

Brief Summary

To determine the safety and tolerability of multiple ascending fixed oral doses of SRA-333 in subjects with mild to moderate Alzheimer's disease.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
SRA-333	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the safety and tolerability of multiple ascending fixed oral dose in subject with mild to moderate Alzheimer's Disease

Secondary Outcomes

Measure	Description	Time Frame
To assess the pharmacokinetics and pharmacodynamics of multiple ascending fixed dose.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of probable AD according to the NINCDS-ADRDA criteria.
Men and postmenopausal or surgically sterile women aged from 50 to 85 inclusive.
Able to give informed consent. Patient's caregiver must consent to participate in the study.

Exclusion Criteria:

Significant neurologic disease other than AD that may affect cognition.
Current clinically significant systemic illness which is likely to deteriorate or affect the subject's safety during the study.

Other exclusions apply

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

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona	85013	United States

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided