NCT00151333

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

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

February 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

September 4, 2009

Status Verified

September 1, 2009

Enrollment Period

2 months

First QC Date

September 6, 2005

Last Update Submit

September 3, 2009

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • To assess the pharmacokinetics and pharmacodynamics of multiple ascending fixed dose.

Interventions

SRA-333DRUG

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Phoenix, Arizona, 85013, United States

Location

Unknown Facility

Fort Lauderdale, Florida, 33321, United States

Location

Unknown Facility

Miami, Florida, 33154, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

February 1, 2005

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

September 4, 2009

Record last verified: 2009-09

Locations

US(3)