You are here

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

Last updated on February 23, 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Alzheimer Disease, Healthy Subjects
NCT00795730
All Genders
18+
Years
Glendale, California
Alzheimer Disease, Healthy
NCT00719394
Males
20+
Years
Tokyo,

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]

Call Now