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A Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of ABT-126 in Subjects With Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01482845
First received: November 21, 2011
Last updated: May 1, 2012
Last verified: March 2012
History of Changes
  Purpose

This study will investigate safety, tolerability and pharmacokinetics of ABT-126 in up to 20 male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.


Condition Intervention Phase
Alzheimer's Disease
 Drug: ABT-126
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-126 in Subjects With Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Safety and tolerability assessments [ Time Frame: From Day 1 through Day 17 ] [ Designated as safety issue: Yes ]
    vital signs, electrocardiogram (ECG), neurological examination, laboratory tests, number of subjects with adverse events, Columbia-Suicide Severity Rating Scale (C-SSRS)


Secondary Outcome Measures:
  • Pharmacokinetic evaluation profile [ Time Frame: Blood collection prior to, and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 72, 120, and 168 hours after dosing on Day 10 ] [ Designated as safety issue: No ]
    Area under curve (AUC), maximum concentration(Cmax), minimum concetration (Cmin), time to peak concentration (Tmax), half-life(t1/2), clearance (CL/F)


Enrollment: 20
Study Start Date: November 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Drug: ABT-126
Dose 1 is given to 8 subjects in Group 1. Dose 2 is given to 8 subjects in Group 2. All doses will be administered once daily in the morning for 10 days.
Drug: Placebo
Placebo is given to 2 subjects each in Group 1 and Group 2. All doses will be administered once daily in the morning for 10 days.
Experimental: Group 2 Drug: ABT-126
Dose 1 is given to 8 subjects in Group 1. Dose 2 is given to 8 subjects in Group 2. All doses will be administered once daily in the morning for 10 days.
Drug: Placebo
Placebo is given to 2 subjects each in Group 1 and Group 2. All doses will be administered once daily in the morning for 10 days.

Detailed Description:

This is a double-blind, placebo-controlled, randomized, multiple-dose, parallel group, multicenter study. Up to 20 male and female subjects with mild to moderate Alzheimer's disease (AD) who are taking stable doses of acetylcholinesterase inhibitors will be enrolled in this study. The study will be conducted in up to four sites. Within 28 days prior to study drug administration, subjects will be screened based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD, Mini-Mental State Examination (MMSE) and Modified Hachinski Ischemic Scale (MHIS) scores, medical history, physical examination, neurological examination, vital signs, ECG, laboratory tests and response to Columbia-Suicide Severity Rating Scale (C-SSRS).

Subjects will be divided into two groups of 10 subjects each. In each group, 8 subjects will receive ABT-126 and two subjects will receive matching placebo. Group 1 will be administered Dose 1 of ABT-126 or placebo. Group 2 will be administered Dose 2 ABT-126 or placebo. All doses will be administered once daily in the morning for 10 days.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Male or female and age between 55 and 90 years, inclusive.
  2. The subject meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease (AD).
  3. The subject has a Mini-Mental State Examination (MMSE) total score of 16 to 26, inclusive, at Screening Visit.
  4. The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening Visit.
  5. The subject must be on a stable dose of donepezil or rivastigmine for at least 1 month prior to study drug administration.
  6. The subject has had a computerized tomography or magnetic resonance imaging scan, interpreted by a radiologist or neurologist, within 36 months prior to randomization and after the subject met NINCDS/ADRDA diagnostic criteria for probable AD. The scan must not show evidence for an alternative etiology for dementia.

Exclusion Criteria

  1. Receipt of an investigational product within 6 weeks prior to study drug administration.
  2. History of significant sensitivity or allergy to any drug.
  3. History of any significant neurological disease other than AD.
  4. Significant current suicidal ideation within 1 month prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening or any history of suicide attempts.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482845

Locations
United States, California
Site Reference ID/Investigator# 62908
Glendale, California, United States, 91206
United States, Florida
Site Reference ID/Investigator# 62904
Hallandale Beach, Florida, United States, 33009
Site Reference ID/Investigator# 62903
Orlando, Florida, United States, 32806
Sponsors and Collaborators
Abbott
Investigators
Study Director: Hana Florian, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01482845     History of Changes
Other Study ID Numbers: M12-970
Study First Received: November 21, 2011
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
 Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013