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Study Evaluating the Safety,Tolerability, PK and PD of SAM-531 in the Subjects With Mild to Moderate Alzheimer's Disease

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Delray Beach, Florida, 33445 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-90 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. 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.

2. 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.

3. 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.

4. Able to participate in all scheduled evaluations with a high probability of completing
all required procedures and neuropsychological tests.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Significant neurological disease other than Alzheimer's disease, which may affect
cognition (eg, epilepsy, Parkinson disease).

2. 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).

3. 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.

4. 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.

NCT00481520
Pfizer
Completed
Study Evaluating the Safety,Tolerability, PK and PD of SAM-531 in the Subjects With Mild to Moderate Alzheimer's Disease

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Study Evaluating the Safety,Tolerability, PK and PD of SAM-531 in the Subjects With Mild to Moderate Alzheimer's Disease
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Alzheimer Disease
  • Drug: SAM-531
  • Other: placebo
  • Experimental: 1
    Intervention: Drug: SAM-531
  • Placebo Comparator: 2
    Intervention: Other: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
January 2008
January 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria

  1. 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.
  2. 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.
  3. 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.
  4. Able to participate in all scheduled evaluations with a high probability of completing all required procedures and neuropsychological tests.

Exclusion Criteria

  1. Significant neurological disease other than Alzheimer's disease, which may affect cognition (eg, epilepsy, Parkinson disease).
  2. 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).
  3. 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.
  4. 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.
Sexes Eligible for Study: All
50 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00481520
3193A1-2000
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
June 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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