NCT00479219

Brief Summary

To assess the pharmacodynamics (PD) of biomarkers amyloid beta peptide 40 and 42 (Ab40 and Ab42) in CSF, following single oral doses of GSI-953, an investigational drug, in healthy young subjects and patients with Alzheimer Disease (AD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at P25-P50 for phase_1 alzheimer-disease

Timeline
Completed

Started May 2007

Shorter than P25 for phase_1 alzheimer-disease

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

July 10, 2008

Status Verified

July 1, 2008

Enrollment Period

5 months

First QC Date

May 25, 2007

Last Update Submit

July 9, 2008

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • We will assess the pharmacodynamics (PD) of biomarkers amyloid beta 40 and 42 in CSF, following single oral doses of GSI-953 in healthy young and Alzheimer's Patients.

    5 months

Study Arms (2)

A

EXPERIMENTAL
Drug: GSI-953

B

PLACEBO COMPARATOR
Other: Placebo

Interventions

GSI-953DRUG
A
PlaceboOTHER
B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For Healthy Young Subjects: Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and 12 lead ECGs.
  • For AD patients: Patients must be generally healthy with the exception of Alzheimer Disease. (same as above)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

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 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 25, 2007

First Posted

May 28, 2007

Study Start

May 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

July 10, 2008

Record last verified: 2008-07

Locations

US(1)