NCT00499200

Brief Summary

The study will include a preliminary pharmacokinetics (PK) / safety / tolerability evaluation in healthy elderly subjects followed by the Receptor Occupancy (RO) evaluations in healthy elderly subjects and in Alzheimer's Disease (AD) subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

July 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

July 9, 2008

Status Verified

July 1, 2008

Enrollment Period

8 months

First QC Date

July 9, 2007

Last Update Submit

July 7, 2008

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

  • To assess the safety and tolerability of ascending single oral doses of SRA-444 in healthy elderly subjects and subjects with Alzheimer's disease

    after each dose group completion

  • To obtain PK profiles and determine the level and duration of 5-HT1A RO of SRA-444 by PET

    1 month

Study Arms (1)

SRA-444 + Placebo

EXPERIMENTAL

Experimental; Placebo

Drug: SRA-444

Interventions

SRA-444DRUG
SRA-444 + Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women from 60 years of age at screening.
  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

You may not qualify if:

  • History of drug abuse within 1 year before study day 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Uppsala, 753 23, Sweden

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

  • Trial Manager

    For Sweden: MedInfoNord@wyeth.com

    PRINCIPAL INVESTIGATOR

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

July 9, 2007

First Posted

July 11, 2007

Study Start

October 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

July 9, 2008

Record last verified: 2008-07

Locations

SE(1)