Alzheimer DiseasePhase 2NCT00481520
Study Evaluating the Safety,Tolerability, PK and PD of SAM-531 in the Subjects With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing SAM-531 in people with Alzheimer Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 7 sites in United States.
Trial summary
The primary purpose of the study is to assess whether SAM-531, an investigational drug, is safe and well tolerated, compared with placebo (a medically inactive substance), in subjects with mild to moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- SAM-531
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2007to Jan 2008
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated written informed consent obtained from the subject or the subject's legally authorized representative (LAR) or next of kin (if applicable), in accordance with the local regulations. The subject's caregiver must also consent to participate in the study.
- Diagnosis of probable Alzheimer's Disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- Men and postmenopausal or surgically sterile women aged from 50 to 90 inclusive. Postmenopausal women must have had 12 months of spontaneous amenorrhea. Surgically sterile women are defined as having a hysterectomy, bilateral ovariectomy [oophorectomy], or bilateral tubal ligation. Men who are sexually active will need to agree to use a form of contraception that is satisfactory as per the investigator.
- Able to participate in all scheduled evaluations with a high probability of completing all required procedures and neuropsychological tests.
Who cannot join
- Significant neurological disease other than Alzheimer's disease, which may affect cognition (eg, epilepsy, Parkinson disease).
- Current diagnosis of a major depressive disorder or other major psychiatric symptom according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Version (DSM-IV-TR).
- Current clinically significant systemic illness, which is likely to deteriorate or affect the subject's safety, influence cognitive assessment or ability to complete the study.
- Any clinically important deviation from normal limits in physical and neurological examination, vital signs, on electrocardiogram (ECG) or clinical laboratory test results that could compromise the study or be detrimental to the subject.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Atlanta, Georgia, 30308
Study site
Bennington, Vermont, 05201
Study site
Delray Beach, Florida, 33445
Study site
Hallandale, Florida, 33009
Study site
Long Branch, New Jersey, 07740
Study site
New York, New York, 10032
Study site
St. Petersburg, Florida, 33709
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) Trial of Multiple Ascending Fixed Doses of SAM-531 in Subjects With Mild to Moderate Alzheimer's Disease.
The primary purpose of the study is to assess whether SAM-531, an investigational drug, is safe and well tolerated, compared with placebo (a medically inactive substance), in subjects with mild to moderate Alzheimer's disease.
- Conditions
- Alzheimer Disease
- Being tested
- SAM-531, placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAM-531Drug
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: SAM-531 |
| 2 | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Routine safety and tolerability will be evaluated.
Measured: 28 days
Secondary outcomes (1)
This study will also investigate the pharmacokinetics(PK, how the drug is metabolized) and pharmacodynamics (PD, how the drug affects bodily and mental function) of SAM-531 compared to placebo.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481520
- Sponsor's protocol ID
- 3193A1-2000
- Status last verified
- Jun 2008
- First submitted
- 30 May 2007
- Last updated
- 30 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) Trial of Multiple Ascending Fixed Doses of SAM-531 in Subjects With Mild to Moderate Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT00481520
- Acronym / sponsor ID
- 3193A1-2000
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 1 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to assess whether SAM-531, an investigational drug, is safe and well tolerated, compared with placebo (a medically inactive substance), in subjects with mild to moderate Alzheimer's disease.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SAM-531 |
| 2 | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed and dated written informed consent obtained from the subject or the subject's legally authorized representative (LAR) or next of kin (if applicable), in accordance with the local regulations. The subject's caregiver must also consent to participate in the study.
- Diagnosis of probable Alzheimer's Disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- Men and postmenopausal or surgically sterile women aged from 50 to 90 inclusive. Postmenopausal women must have had 12 months of spontaneous amenorrhea. Surgically sterile women are defined as having a hysterectomy, bilateral ovariectomy [oophorectomy], or bilateral tubal ligation. Men who are sexually active will need to agree to use a form of contraception that is satisfactory as per the investigator.
- Able to participate in all scheduled evaluations with a high probability of completing all required procedures and neuropsychological tests.
Key exclusion criteria (4 listed)
- Significant neurological disease other than Alzheimer's disease, which may affect cognition (eg, epilepsy, Parkinson disease).
- Current diagnosis of a major depressive disorder or other major psychiatric symptom according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Version (DSM-IV-TR).
- Current clinically significant systemic illness, which is likely to deteriorate or affect the subject's safety, influence cognitive assessment or ability to complete the study.
- Any clinically important deviation from normal limits in physical and neurological examination, vital signs, on electrocardiogram (ECG) or clinical laboratory test results that could compromise the study or be detrimental to the subject.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAM-531 | Drug | 1 |
| placebo | Other | 2 |
Primary outcome
Routine safety and tolerability will be evaluated.
Time frame: 28 days
1 secondary outcome
This study will also investigate the pharmacokinetics(PK, how the drug is metabolized) and pharmacodynamics (PD, how the drug affects bodily and mental function) of SAM-531 compared to placebo.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAM-531 in people with Alzheimer Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 7 sites in United States.
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 4 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 30 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Routine safety and tolerability will be evaluated. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2009.