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Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

Primary Purpose

Alzheimer Disease

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo

SAM-531 1.5 mg

SAM-531 3.0 mg

SAM-531 5.0 mg

Donepezil

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of probable Alzheimer Disease according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Diseases and Related Disorders Association (NINCDS-ADRDA) criteria.
Mini-Mental State Examination (MMSE) score of 12 to 24 at screening
Rosen Modified Hachinski Ischemic score < or equal to 4 at screening.

Exclusion Criteria:

Relevant neurologic disease other than Alzheimer Disease that may affect cognition or ability to complete the study.
Current major depressive disorder or other current major psychiatric disorder.
History of clinically evident stroke or clinically important carotid or vertebrobasilar stenosis or plaque.
Use of prescription or nonprescription medications for cognitive enhancement (including memantine, ginkgo biloba, huperzine A, and cholinesterase inhibitors) within 3 months before the baseline visit.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Arm Description

Placebo

SAM-531 1.5 mg

SAM-531 3.0 mg

SAM-531 5.0 mg

Donepezil

Outcomes

Primary Outcome Measures

Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24

14-item scale to assess severity of cognitive impairment in Alzheimer's Disease. Items: word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, recall of test instructions, spoken language ability, word-finding difficulty, comprehension of spoken language, concentration/distractibility, number cancellation and executive maze. Rating scale ranged from 0 (not present) to 5 (severe). Total score was sum of individual scores (items 1-11) and ranged from 0 to 70 with higher scores indicating greater cognitive impairment.

Secondary Outcome Measures

Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24

Caregiver interview-based instrument assessing 10 areas of activities of daily living (ADL) to measure participant's actual performance over the previous 2 weeks. Items included hygiene, dressing, continence, eating, meal preparation, telephoning, outings, finance/correspondence, medications and leisure/housework. Responses scored as 1 (yes) or 0 (no), response of "Not Applicable" was not scored. Total DAD score was sum of scores for 40 items, expressed as a percentage of the number of items answered yes or no. Total score ranged from 0 to 100, higher scores represented less disability in ADL.

Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24

Caregiver interview-based rating scale assessed 10 behavioral, 2 neurovegetative disturbances occurring in dementia: delusions, hallucination, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, aberrant motor behavior, appetite/eating disorders and sleep/nightime behavior disorders. Each symptom score derived by symptom frequency (1 [occasionally] to 4 [very frequently] * symptom severity (1 [mild] to 3 [severe]) and ranged 0-12. Total score = sum of symptom scores; range 0-144, higher score indicating greater behavioral disturbances

Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24

Caregiver and participant interview-based tool to rate the overall impression of participant's clinical change of the disease over time. Areas covered in the interview include: relevant history, observation/evaluation, mental/cognitive state, behavior and functioning. Change categorized into 1 of 7 categories: marked improvement, moderate improvement, minimal improvement, no change, minimal worsening, moderate worsening, marked worsening.

Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24

CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total Errors=total number of incorrect boxes chosen plus adjustment for estimated possible errors on problems, attempts, and recalls not reached. Total score 0 to 106, lower scores=better performance.

Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24

CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of patterns presented at last stage successfully completed and ranged from 2 to 6, higher scores indicated better performance.

Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24

CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of correct choices made on the first attempt at each Stage. Total score ranged from 0 to 20, higher scores indicated better performance.

Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24

CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 4 box assessments the maximum number of errors per trial was 20. Test ended with 20 errors in a trial. Less than 20 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 39. Lower scores: better performance.

Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24

CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 6 box assessments the maximum number of errors per trial was 30. Test ended with 30 errors in a trial. Less than 30 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 59. Lower scores: better performance.

Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24

CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 8 box assessments the maximum number of errors per trial was 40. Test ended with 40 errors in a trial. Less than 40 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 79. Lower scores: better performance.

Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24

CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials for each assessment. Possible errors for each successful assessment: 4 box 0-38; 6 box 0-58; 8 box 0-78. Between Errors for N Boxes was the cumulative number of errors per each successful trial. Total scores ranged from 0 to 175. Lower scores indicated better performance.

Change From Baseline in CANTAB SWM Strategy at Week 24

CANTAB-SWM assessed participant's ability to strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials per assessment. Strategy score was the number of unique boxes the participant searched in the two 6 and 8 box trials. 6 box trial scores ranged from 1 (1 box searched for all 6 tokens) to 6 (6 boxes searched for 6 tokens). 8 box trial score ranged from 1 (1 box searched) to 8 (8 boxes searched for 8 tokens). Total of the 4 trial scores ranged from 4 to 28. Lower score indicated better performance.

Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24

CANTAB-PRM assessed participant's visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Latency in correct responses ranged from 0 to infinity millisecond (msec), lower scores indicated better performance.

Change From Baseline in CANTAB PRM-Percentage Correct at Week 24

CANTAB-PRM assessed participant's visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Correct response total expressed as a percentage, ranged from 0 to 100, higher scores indicated better performance.

Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24

CANTAB-RTI assessed participant's reaction, movement time and vigilance during a 5-choice reaction time trial and to measure anticipatory/premature and perseverative responses. In the trial, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Accuracy was the total number of trials where participant responded correctly. Total ranged from 0 to 30, higher score indicated better performance.

Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24

CANTAB-RTI assessed participant's reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Movement Time was the time from release of press pad to screen touch where the spot had been in trials the participant responded correctly. Possible score ranged from 100 to 5100 msec, lower score indicated better performance.

Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24

CANTAB-RTI assessed participant's reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.

Change From Baseline in CANTAB RTI Simple Movement Time at Week 24

CANTAB-RTI assessed participant's reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Movement Time was the time from release of press pad to touch the screen where the spot had been in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.

Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24

CANTAB-RTI assessed participant's reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.

Percentage of Participants Who Were Responders at Week 24

Responder defined as a participant who demonstrated an improvement of at least 3 points from baseline in the ADAS-Cog total score and no worsening in the DAD total score and in ADCS-CGIC. Participants were considered a responder at Week 24 if all 3 criteria were met.

Full Information

NCT ID

NCT00895895

First Posted

May 7, 2009

Last Updated

December 21, 2012

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00895895

Brief Title

Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

Official Title

A 52-Week, Two-Period, Multicenter, Randomized, Double-Blind, Donepezil-Referenced, Placebo-Controlled, Efficacy And Safety Study Of 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Terminated

Why Stopped

See termination reason in detailed description.

Study Start Date

May 2009 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531, donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage levels or donepezil in period I will continue with the same study drug (period II).

Detailed Description

The study was stopped (date of termination was 13April2011) due to a 6 month interim analysis: all of the 3 SAM-531 dosage levels were declared futile. There were no safety concerns.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

526 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Arm Type

Experimental

Arm Description

SAM-531 1.5 mg

Arm Title

Arm Type

Experimental

Arm Description

SAM-531 3.0 mg

Arm Title

Arm Type

Experimental

Arm Description

SAM-531 5.0 mg

Arm Title

Arm Type

Active Comparator

Arm Description

Donepezil

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Capsules SAM-531 placebo and 5 mg tablet encapsulated Donepezil placebo capsules, once a day during 24 weeks.

Intervention Type

Drug

Intervention Name(s)

SAM-531 1.5 mg

Intervention Description

Capsules SAM-531 1.5 mg, once a day during 52 weeks.

Intervention Type

Drug

Intervention Name(s)

SAM-531 3.0 mg

Intervention Description

Capsules SAM-531 3.0 mg, once a day during 52 weeks.

Intervention Type

Drug

Intervention Name(s)

SAM-531 5.0 mg

Intervention Description

Capsules SAM-531 5.0 mg, once a day during 24 weeks or 52 weeks.

Intervention Type

Drug

Intervention Name(s)

Donepezil

Intervention Description

Encapsulated Donepezil 5 mg tablets, once a day during 52 weeks. After Day 42, the dose can up titrated up to 10 mg of Donepezil.

Primary Outcome Measure Information:

Title

Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24

Description

Time Frame

Baseline, Week 24

Secondary Outcome Measure Information:

Title

Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24

Description

CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of patterns presented at last stage successfully completed and ranged from 2 to 6, higher scores indicated better performance.

Time Frame

Baseline, Week 24

Title

Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24

Description

CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of correct choices made on the first attempt at each Stage. Total score ranged from 0 to 20, higher scores indicated better performance.

Time Frame

Baseline, Week 24

Title

Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24

Description

CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 6 box assessments the maximum number of errors per trial was 30. Test ended with 30 errors in a trial. Less than 30 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 59. Lower scores: better performance.

Time Frame

Baseline, Week 24

Title

Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24

Description

CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 8 box assessments the maximum number of errors per trial was 40. Test ended with 40 errors in a trial. Less than 40 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 79. Lower scores: better performance.

Time Frame

Baseline, Week 24

Title

Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in CANTAB SWM Strategy at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in CANTAB PRM-Percentage Correct at Week 24

Description

CANTAB-PRM assessed participant's visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Correct response total expressed as a percentage, ranged from 0 to 100, higher scores indicated better performance.

Time Frame

Baseline, Week 24

Title

Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24

Description

CANTAB-RTI assessed participant's reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.

Time Frame

Baseline, Week 24

Title

Change From Baseline in CANTAB RTI Simple Movement Time at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24

Description

CANTAB-RTI assessed participant's reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.

Time Frame

Baseline, Week 24

Title

Percentage of Participants Who Were Responders at Week 24

Description

Time Frame

Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of probable Alzheimer Disease according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Diseases and Related Disorders Association (NINCDS-ADRDA) criteria. Mini-Mental State Examination (MMSE) score of 12 to 24 at screening Rosen Modified Hachinski Ischemic score < or equal to 4 at screening. Exclusion Criteria: Relevant neurologic disease other than Alzheimer Disease that may affect cognition or ability to complete the study. Current major depressive disorder or other current major psychiatric disorder. History of clinically evident stroke or clinically important carotid or vertebrobasilar stenosis or plaque. Use of prescription or nonprescription medications for cognitive enhancement (including memantine, ginkgo biloba, huperzine A, and cholinesterase inhibitors) within 3 months before the baseline visit.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85050

Country

United States

Facility Name

Pfizer Investigational Site

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92626

Country

United States

Facility Name

Pfizer Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Pfizer Investigational Site

City

Garden Grove

State/Province

California

ZIP/Postal Code

92845

Country

United States

Facility Name

Pfizer Investigational Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Pfizer Investigational Site

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

Facility Name

Pfizer Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

Pfizer Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80239

Country

United States

Facility Name

Pfizer Investigational Site

City

aTLANTIS

State/Province

Florida

ZIP/Postal Code

33462

Country

United States

Facility Name

Pfizer Investigational Site

City

Brooksville

State/Province

Florida

ZIP/Postal Code

34601

Country

United States

Facility Name

Pfizer Investigational Site

City

Hallandale Beach

State/Province

Florida

ZIP/Postal Code

33009

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Pfizer Investigational Site

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Pfizer Investigational Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33317

Country

United States

Facility Name

Pfizer Investigational Site

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33702

Country

United States

Facility Name

Pfizer Investigational Site

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33709

Country

United States

Facility Name

Pfizer Investigational Site

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351

Country

United States

Facility Name

Pfizer Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Pfizer Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Pfizer Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

Pfizer Investigational Site

City

Elk Grove Village

State/Province

Illinois

ZIP/Postal Code

60007

Country

United States

Facility Name

Pfizer Investigational Site

City

Park Ridge

State/Province

Illinois

ZIP/Postal Code

60068

Country

United States

Facility Name

Pfizer Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Pfizer Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Pfizer Investigational Site

City

Cedarhurst

State/Province

New York

ZIP/Postal Code

11516

Country

United States

Facility Name

Pfizer Investigational Site

City

Staten Island

State/Province

New York

ZIP/Postal Code

10312

Country

United States

Facility Name

Pfizer Investigational Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43623

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

Facility Name

Pfizer Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74104

Country

United States

Facility Name

Pfizer Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Pfizer Investigational Site

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18104

Country

United States

Facility Name

Pfizer Investigational Site

City

Franklin

State/Province

Tennessee

ZIP/Postal Code

37067

Country

United States

Facility Name

Pfizer Investigational Site

City

Bennington

State/Province

Vermont

ZIP/Postal Code

05201

Country

United States

Facility Name

Pfizer Investigational Site

City

Middleton

State/Province

Wisconsin

ZIP/Postal Code

53562

Country

United States

Facility Name

Pfizer Investigational Site

City

C.a.b.a.

State/Province

Buenos Aires

ZIP/Postal Code

C1126AAB

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

1022

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Ciudad de Buenos Aires

ZIP/Postal Code

1022

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Ciudad de Buenos Aires

ZIP/Postal Code

C1425BWO

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Santiago

ZIP/Postal Code

7500922

Country

Chile

Facility Name

Pfizer Investigational Site

City

Santiago

ZIP/Postal Code

7530193

Country

Chile

Facility Name

Pfizer Investigational Site

City

Santiago

ZIP/Postal Code

7630000

Country

Chile

Facility Name

Pfizer Investigational Site

City

Santiago

ZIP/Postal Code

8330838

Country

Chile

Facility Name

Pfizer Investigational Site

City

Vina del Mar

ZIP/Postal Code

2520997

Country

Chile

Facility Name

Pfizer Investigational Site

City

Bogota

State/Province

Cundinamarca

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Pereira

State/Province

Risaralda

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Bucamaranga

State/Province

Santander

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Cali

State/Province

Valle

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Valle del Cauca

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Shatin, N.T.

State/Province

Hong Kong SAR, China

Country

Hong Kong

Facility Name

Pfizer Investigational Site

City

Hong Kong

Country

Hong Kong

Facility Name

Pfizer Investigational Site

City

Hachioji

State/Province

Tokyo

Country

Japan

Facility Name

Pfizer Investigational Site

City

Chiba

Country

Japan

Facility Name

Pfizer Investigational Site

City

Fukuoka

Country

Japan

Facility Name

Pfizer Investigational Site

City

Hiroshima

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kanagawa

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kumamoto

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kyoto

Country

Japan

Facility Name

Pfizer Investigational Site

City

Nagano

Country

Japan

Facility Name

Pfizer Investigational Site

City

Nagasaki

Country

Japan

Facility Name

Pfizer Investigational Site

City

Shizuoka

Country

Japan

Facility Name

Pfizer Investigational Site

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Saltillo

State/Province

Coahuila

ZIP/Postal Code

25000

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Aguascalientes

ZIP/Postal Code

20127

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Auckland

ZIP/Postal Code

0622

Country

New Zealand

Facility Name

Pfizer Investigational Site

City

Hamilton

ZIP/Postal Code

3240

Country

New Zealand

Facility Name

Pfizer Investigational Site

City

Krakow

ZIP/Postal Code

31-531

Country

Poland

Facility Name

Pfizer Investigational Site

City

Poznan

ZIP/Postal Code

61-289

Country

Poland

Facility Name

Pfizer Investigational Site

City

Wroclaw

ZIP/Postal Code

50-088

Country

Poland

Facility Name

Pfizer Investigational Site

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200317

Country

Romania

Facility Name

Pfizer Investigational Site

City

Timisoara

State/Province

Timis

ZIP/Postal Code

300736

Country

Romania

Facility Name

Pfizer Investigational Site

City

Bucuresti

ZIP/Postal Code

010825

Country

Romania

Facility Name

Pfizer Investigational Site

City

Bucuresti

ZIP/Postal Code

011241

Country

Romania

Facility Name

Pfizer Investigational Site

City

Bucuresti

ZIP/Postal Code

041914

Country

Romania

Facility Name

Pfizer Investigational Site

City

Bucuresti

ZIP/Postal Code

050098

Country

Romania

Facility Name

Pfizer Investigational Site

City

Nikolskoe village

State/Province

Gatchina district, Leningrad region

ZIP/Postal Code

188357

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Kazan

ZIP/Postal Code

420101

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

123182

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Novosibirsk

ZIP/Postal Code

630054

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

190005

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

192019

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

198103

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Smolensk

ZIP/Postal Code

214018

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Yaroslavl

ZIP/Postal Code

150030

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Bloemfontein

State/Province

Free State

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0041

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Bellville

State/Province

Western Cape

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Cape Town

ZIP/Postal Code

7530

Country

South Africa

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3193A1-2005&StudyName=Study%20Comparing%203%20Dosage%20Levels%20Of%20SAM-531%20In%20Outpatients%20With%20Mild%20To%20Moderate%20Alzheimer%20Disease

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

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Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

Alzheimer Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial