NCT00481520

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_2 alzheimer-disease

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_2 alzheimer-disease

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

September 30, 2009

Status Verified

June 1, 2008

Enrollment Period

7 months

First QC Date

May 30, 2007

Last Update Submit

September 28, 2009

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • Routine safety and tolerability will be evaluated.

    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.

    28 days

Study Arms (2)

1

EXPERIMENTAL
Drug: SAM-531

2

PLACEBO COMPARATOR
Other: placebo

Interventions

SAM-531DRUG
1
placeboOTHER
2

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Delray Beach, Florida, 33445, United States

Location

Unknown Facility

Hallandale, Florida, 33009, United States

Location

Unknown Facility

St. Petersburg, Florida, 33709, United States

Location

Unknown Facility

Atlanta, Georgia, 30308, United States

Location

Unknown Facility

Long Branch, New Jersey, 07740, United States

Location

Unknown Facility

New York, New York, 10032, United States

Location

Unknown Facility

Bennington, Vermont, 05201, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

SAM-531

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2007

First Posted

June 1, 2007

Study Start

June 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

September 30, 2009

Record last verified: 2008-06

Locations

US(7)