NCT00842673

Brief Summary

This study will investigate the ability of ST101 to improve memory in people with Alzheimer's disease. This study also will examine the safety and tolerability of the drug. This study is evaluating 3 different dose levels of ST101 and placebo. Patients will have a 1 in 4 chance of getting placebo.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2009

Geographic Reach
2 countries

18 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, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 7, 2012

Status Verified

June 1, 2012

Enrollment Period

1.6 years

First QC Date

February 10, 2009

Last Update Submit

June 5, 2012

Conditions

Alzheimer's Disease

Keywords

DementiaAlzheimer Type Senile DementiaCognitive impairment

Outcome Measures

Primary Outcomes (1)

  • Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)

    Baseline, 4 weeks, 8 weeks,12 weeks

Secondary Outcomes (3)

  • Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

    Baseline, 4 weeks, 8 weeks, 12 weeks

  • Neuropsychiatric Inventory (NPI)

    Baseline, 4 weeks, 8 weeks, 12 weeks

  • Alzheimer's Disease Cooperative Study- Clinical Global Impression (ADCS-CGI)

    Baseline (severity); 4 weeks, 8 weeks, 12 weeks (change)

Study Arms (4)

1

EXPERIMENTAL

30 mg ST101

Drug: ST101

2

EXPERIMENTAL

90 mg ST101

Drug: ST101

3

EXPERIMENTAL

180 mg ST101

Drug: ST101

4

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

ST101DRUG

30 mg; administered once/day

1
PlaceboDRUG

placebo to match ST101 tablets

4

Eligibility Criteria

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

You may qualify if:

  • Diagnostic evidence of mild to moderate Alzheimer's disease.
  • CT or MRI results within the past 12 months that rule out dementia due to non-Alzheimer's etiology.
  • A reliable and capable caregiver.

You may not qualify if:

  • Subjects who reside in a skilled nursing facility.
  • Subjects with B12 or folate deficiency.
  • Subjects with chronic hepatic disease.
  • Subjects with a recent history of hematologic/oncologic disorders.
  • Subjects who have experienced a myocardial infarction with the past year.
  • Dementia caused or complicated by other organic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Costa Mesa, California, United States

Location

Unknown Facility

Redlands, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Walnut Creek, California, United States

Location

Unknown Facility

Deerfield Beach, Florida, United States

Location

Unknown Facility

Delray Beach, Florida, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

West Palm Beach, Florida, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Jenkinton, Pennsylvania, United States

Location

Unknown Facility

Wichita Falls, Texas, United States

Location

Unknown Facility

Bennington, Vermont, United States

Location

Unknown Facility

Peterborough, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 12, 2009

Study Start

February 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

June 7, 2012

Record last verified: 2012-06

Locations

CA(3)US(15)