A Safety and Tolerability Study of ABT-126 in Elderly

Abbott

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: ABT-126

Study type: Interventional

Funder types: Industry

Identifiers

NCT00867399

M10-717

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

30 participants in 2 patient groups

20mg of ABT-126 QD

Active Comparator group

Description:

20 mg of ABT-126 QD for 10 days

Treatment:

Drug: ABT-126

30mg and 45mg ABT-126 QD

Active Comparator group

Description:

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

Treatment:

Drug: ABT-126