Trial | NCT00842673  Report issue

Title

Preliminary Efficacy and Safety Study of ST101 in Alzheimer's Disease
A Double-Blind Placebo-Controlled Preliminary Study of the Efficacy, Safety and Tolerability of ST101 Tablets in the Treatment of Alzheimer's Disease

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    st101 ...

  • Study Participants

    168
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.
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 Started
Feb 28
2009
Primary Completion
Sep 30
2010
Study Completion
Sep 30
2010
Last Update
Jun 07
2012
Estimate

Drug ST101

30 mg; administered once/day

Drug ST101

90 mg; administered once/day

Drug ST101

180 mg; administered once/day

Drug Placebo

placebo to match ST101 tablets

1 Experimental

30 mg ST101

2 Experimental

90 mg ST101

3 Experimental

180 mg ST101

4 Placebo Comparator

Placebo

Criteria 

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
No Results Posted