NCT00867399

Brief Summary

The objectives of this study are to assess the safety, tolerability and pharmacokinetics of ABT-126 in elderly subjects.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 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

Study Start

First participant enrolled

March 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Last Updated

November 2, 2010

Status Verified

September 1, 2010

Enrollment Period

2 months

First QC Date

March 19, 2009

Last Update Submit

October 31, 2010

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

  • Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)

    Study Days -1 thru Day 28

  • Assess the Pharmacokinetics

    Study Days -1 thru Day 28

Study Arms (2)

20mg of ABT-126 QD

ACTIVE COMPARATOR

20 mg of ABT-126 QD for 10 days

Drug: ABT-126

30mg and 45mg ABT-126 QD

ACTIVE COMPARATOR

30 mg and 45mg of ABT-126 QD for 21 days

Drug: ABT-126

Interventions

ABT-126DRUG

See arm for details

20mg of ABT-126 QD30mg and 45mg ABT-126 QD

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Healthy male or female subjects 65 years or greater.
  • Has a MMSE score of 27 or higher.

You may not qualify if:

  • History of dementia including by not limited to Alzheimer's disease, Parkinson's disease and mult-infarct dementia.
  • History of any significant neurological disease.
  • Has an estimated creatinine clearance \< 30 mL/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 17283

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

ABT-126

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

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

March 19, 2009

First Posted

March 23, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2009

Last Updated

November 2, 2010

Record last verified: 2010-09

Locations

US(1)