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Completed

NCT Number: NCT00151333

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

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SRA-333

Drug

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.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics Trial of Multiple Ascending Fixed Doses of SRA-333 in Subjects With Mild to Moderate Alzheimer's Disease.

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 8, 2005
Registry last updated
Sep 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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