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Alzheimer's DiseasePhase 2NCT00842816

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

A Phase 2 study testing ST101 in people with Alzheimer's Disease, run by Sonexa Therapeutics, Inc. at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will investigate the ability of ST101 to improve memory in people with Alzheimer's disease who currently receive 10 mg Aricept® (donepezil) per day. This study also will examine the safety and tolerability of the drug. This study is evaluating 3 different dose levels of ST101 and placebo. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
ST101
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
210 participants
Where
30 sitesin 2 countries
Study dates
Feb 2009to May 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must be receiving concurrent treatment with 10 mg/day of Aricept (donepezil). The dose shall have been stable for three (3) months (90 days) prior to Screening.
  • Diagnostic evidence of Moderate to Moderately Severe Probable Alzheimer's disease
  • CT or MRI results within the past 18 months that rule out dementia due to non-Alzheimer's etiology.
  • A reliable and capable caregiver.

Who cannot join

  • 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.

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

United States27 sites

  • Study site

    Bennington, Vermont

  • Study site

    Brooksville, Florida

  • Study site

    Columbus, Ohio

  • Study site

    Costa Mesa, California

  • Study site

    Decatur, Georgia

  • Study site

    Deerfield Beach, Florida

  • Study site

    Delray Beach, Florida

  • Study site

    Durham, North Carolina

  • Study site

    East Providence, Rhode Island

  • Study site

    Hamden, Connecticut

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Jenkinton, Pennsylvania

  • Study site

    Kirkland, Washington

  • Study site

    Norristown, Pennsylvania

  • Study site

    Orlando, Florida

  • Study site

    Redlands, California

  • Study site

    San Diego, California

  • Study site

    Shreveport, Louisiana

  • Study site

    St. Petersburg, Florida

  • Study site

    Summit, New Jersey

  • Study site

    Toledo, Ohio

  • Study site

    Toms River, New Jersey

  • Study site

    Tucson, Arizona

  • Study site

    Walnut Creek, California

  • Study site

    West Palm Beach, Florida

  • Study site

    Wichita Falls, Texas

Other trials in United States

Canada3 sites

  • Study site

    Montreal, Quebec

  • Study site

    Peterborough, Ontario

  • Study site

    Toronto, Ontario

Other trials in Canada

About this study

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 in Subjects Concurrently Receiving Donepezil (Aricept®)

This study will investigate the ability of ST101 to improve memory in people with Alzheimer's disease who currently receive 10 mg Aricept® (donepezil) per day. 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. All eligible subjects will be provided with bottles of 10 mg Aricept (donepezil) during the study drug administration part of the study.

Read the 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.

Being tested
ST101, Placebo
Keywords
Dementia, Alzheimer Type Senile Dementia, Cognitive impairment
Medical subject headings
Alzheimer Disease, Dementia, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ST101Drug

    10 mg; administered once/day

  • ST101Drug

    60 mg; administered once/day

  • ST101Drug

    120 mg; administered once/day

  • PlaceboDrug

    placebo tablets to match ST101 tablets

Study groups in NCT00842816
Study groupRoleWhat they receive
1Experimental10 mg ST101
Receives: Drug: ST101
2Experimental60 mg ST101
Receives: Drug: ST101
3Experimental120 mg ST101
Receives: Drug: ST101
4Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog)

    Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary outcomes (3)

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

    Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

  2. Neuropsychiatric Inventory (NPI)

    Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00842816
Sponsor's protocol ID
ST101-A001-202
Status last verified
Jun 2012
First submitted
10 Feb 2009
Last updated
7 Jun 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ST101 in people with Alzheimer's Disease, run by Sonexa Therapeutics, Inc. at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog) (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00842816.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2012.

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