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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00151333

Enrollment

Registered

2005-09-08

Start date

2005-02-28

Completion date

2005-04-30

Last updated

2009-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

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.

Interventions

DRUGSRA-333

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To assess the pharmacokinetics and pharmacodynamics of multiple ascending fixed dose.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026