NCT00795730

Brief Summary

This is a multiple dose study of NSA-789, the purpose of which is to assess the safety and tolerability in healthy subjects and subjects with Alzheimer's Disease

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 alzheimer-disease

Timeline
Completed

Started Jan 2009

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

First Submitted

Initial submission to the registry

November 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

November 20, 2008

Last Update Submit

August 17, 2021

Conditions

Alzheimer DiseaseHealthy Subjects

Keywords

Alzheimer's Diseaseschizophrenia

Outcome Measures

Primary Outcomes (1)

  • Adverse event monitoring as specific tests that will be done to monitor safety (ECGs, certain laboratory tests, vital signs) and tolerability

    6 months

Secondary Outcomes (1)

  • Pharmacokinetic and pharmcodynamic parameters

    6 months

Study Arms (2)

placebo

PLACEBO COMPARATOR
Other: placebo

NSA-789

EXPERIMENTAL
Drug: NSA-789

Interventions

NSA-789DRUG
NSA-789
placeboOTHER
placebo

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women aged 18 - 50 years (healthy subjects) or greater than 55 years old (subjects with Alzheimer's Disease)
  • Women must be surgically sterile or postmenopausal
  • Subjects with Alzheimer's Disease must be generally healthy, but may have a stable, chronic illness if well controlled.

You may not qualify if:

  • Healthy subjects may not be on any prescription or investigation drugs within 30 days of start of study.
  • Subjects with Alzheimer's Disease may not be on any cholinesterase inhibitors such as donepezil (Aricept®) or rivastigmine (Exelon®) within 4 weeks of the start of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseSchizophrenia

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic 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
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2008

First Posted

November 21, 2008

Study Start

January 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

August 20, 2021

Record last verified: 2021-08

Locations

US(1)