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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 November 13, 2019

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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Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety,Tolerability, PK and PD of SAM-531 in the Subjects With Mild to Moderate Alzheimer's Disease
Official Title  ICMJE 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.
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: SAM-531
  • Other: placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: SAM-531
  • Placebo Comparator: 2
    Intervention: Other: placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 30, 2007)
72
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion DateJanuary 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00481520
Other Study ID Numbers  ICMJE 3193A1-2000
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJune 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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