Preliminary Efficacy and Safety Study of ST101 in Alzheimer's Disease

Sponsor
Sonexa Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00842673
Collaborator
(none)
168
18
4
19
9.3
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Alzheimer's disease (AD) is a progressive and fatal neurological illness. It produces changes in the brain that include loss of cells and accumulation of abnormal protein deposits. Initial symptoms are cognitive, with deficiencies in short-term memory the most common symptom. As the disease progresses so does the severity of cognitive deficiency. Loss of speech and immobility occur in the terminal stages There is no cure for AD and no marketed treatment that modifies the underlying disease process. Available therapies improve some symptoms of AD by increasing brain concentrations of molecules involved in cognition. ST101 differs from marketed therapies in that it has demonstrated two actions in animal research testing. It improves cognition and it also reduces the accumulation of abnormal protein deposits in the brain. These two properties suggest that ST101 may be a promising agent for the treatment of AD. This study is designed as a preliminary dose exploration/proof-of-concept investigation of the ability of ST101 to improve cognition during 12 weeks of administration.

Study Design

Study Type:
Interventional
Actual Enrollment :
168 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-Blind Placebo-Controlled Preliminary Study of the Efficacy, Safety and Tolerability of ST101 Tablets in the Treatment of Alzheimer's Disease
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

30 mg ST101

Drug: ST101
30 mg; administered once/day

Experimental: 2

90 mg ST101

Drug: ST101
90 mg; administered once/day

Experimental: 3

180 mg ST101

Drug: ST101
180 mg; administered once/day

Placebo Comparator: 4

Placebo

Drug: Placebo
placebo to match ST101 tablets

Outcome Measures

Primary Outcome Measures

  1. Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog) [Baseline, 4 weeks, 8 weeks,12 weeks]

Secondary Outcome Measures

  1. Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [Baseline, 4 weeks, 8 weeks, 12 weeks]

  2. Neuropsychiatric Inventory (NPI) [Baseline, 4 weeks, 8 weeks, 12 weeks]

  3. Alzheimer's Disease Cooperative Study- Clinical Global Impression (ADCS-CGI) [Baseline (severity); 4 weeks, 8 weeks, 12 weeks (change)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Costa Mesa California United States
2 Redlands California United States
3 San Diego California United States
4 Walnut Creek California United States
5 Deerfield Beach Florida United States
6 Delray Beach Florida United States
7 Orlando Florida United States
8 West Palm Beach Florida United States
9 Indianapolis Indiana United States
10 Shreveport Louisiana United States
11 Durham North Carolina United States
12 Toledo Ohio United States
13 Jenkinton Pennsylvania United States
14 Wichita Falls Texas United States
15 Bennington Vermont United States
16 Peterborough Ontario Canada
17 Toronto Ontario Canada
18 Montreal Quebec Canada

Sponsors and Collaborators

  • Sonexa Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sonexa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00842673
Other Study ID Numbers:
  • ST101-A001-201
First Posted:
Feb 12, 2009
Last Update Posted:
Jun 7, 2012
Last Verified:
Jun 1, 2012
Keywords provided by Sonexa Therapeutics, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2012