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Safety, Tolerability, and Pharmacokinetics of ABT-354 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ABT-354

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable Alzheimer's Disease
Has a Mini-Mental State Examination total score of 16 to 26, inclusive, at Screening
Has a Modified Hachinski Ischemia Scale score of ≤ 4 at Screening
On a stable dose of - donepezil, galantamine or rivastigmine for at least 30 days prior to study drug administration
Has had a computerized tomography or magnetic resonance imaging scan, interpreted by a radiologist or neurologist, within 36 months prior to randomization

Exclusion Criteria:

Receipt of any depot drug by injection within 30 days prior to study drug administration
Receipt of an investigational product within a time period equal to 10 half-lives, if known, or within 6 weeks prior to study drug administration
History of any significant neurological disease other than Alzheimer's Disease
History of significant sensitivity or allergy to multiple drugs based on medical records and/or the opinion of the investigator
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 completed at Screening or any history of suicide attempts

Sites / Locations

Site Reference ID/Investigator# 106999
Site Reference ID/Investigator# 106998
Site Reference ID/Investigator# 107000

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1, low dose

Group 2, high dose

Arm Description

ABT-354

Outcomes

Primary Outcome Measures

Vital signs

ECG (electrocardiogram)

Neurological exam

Laboratory tests

Hematology, Chemistry, Urinalysis

Number of subject with adverse events

C-SSRS (Columbia-Suicide Severity Rating Scale)

Secondary Outcome Measures

Pharmacokinetic parameters

Cmax, Cmin, Tmax, AUC, t-1/2, CL/F

Full Information

NCT ID

NCT01908010

First Posted

July 23, 2013

Last Updated

December 9, 2013

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT01908010

Brief Title

Safety, Tolerability, and Pharmacokinetics of ABT-354 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Official Title

A Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-354 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will investigate safety, tolerability and pharmacokinetics of ABT-354 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.

Detailed Description

This is a double-blind, placebo-controlled, randomized, multiple-dose, 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. 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). The study will be performed in two groups of 10 subjects each. In each group of 10 subjects, 7 subjects will be randomly assigned to receive ABT-354 and 3 subjects to receive matching placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

Alzheimer's disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1, low dose

Arm Type

Experimental

Arm Description

ABT-354

Arm Title

Group 2, high dose

Arm Type

Experimental

Arm Description

ABT-354

Intervention Type

Drug

Intervention Name(s)

ABT-354

Intervention Description

ABT-354 Low Dose

Intervention Type

Drug

Intervention Name(s)

ABT-354

Intervention Description

ABT-354 High Dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Vital signs

Time Frame

Up to Day 10

Title

ECG (electrocardiogram)

Time Frame

Up to Day 10

Title

Neurological exam

Time Frame

Up to Day 10

Title

Laboratory tests

Description

Hematology, Chemistry, Urinalysis

Time Frame

Up to Day 10

Title

Number of subject with adverse events

Time Frame

Up to Day 10

Title

C-SSRS (Columbia-Suicide Severity Rating Scale)

Time Frame

Up to Day 10

Secondary Outcome Measure Information:

Title

Pharmacokinetic parameters

Description

Cmax, Cmin, Tmax, AUC, t-1/2, CL/F

Time Frame

Up to Day 10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable Alzheimer's Disease Has a Mini-Mental State Examination total score of 16 to 26, inclusive, at Screening Has a Modified Hachinski Ischemia Scale score of ≤ 4 at Screening On a stable dose of - donepezil, galantamine or rivastigmine for at least 30 days prior to study drug administration Has had a computerized tomography or magnetic resonance imaging scan, interpreted by a radiologist or neurologist, within 36 months prior to randomization Exclusion Criteria: Receipt of any depot drug by injection within 30 days prior to study drug administration Receipt of an investigational product within a time period equal to 10 half-lives, if known, or within 6 weeks prior to study drug administration History of any significant neurological disease other than Alzheimer's Disease History of significant sensitivity or allergy to multiple drugs based on medical records and/or the opinion of the investigator 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 completed at Screening or any history of suicide attempts

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerard Marek, MD

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 106999

City

Miami

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

Site Reference ID/Investigator# 106998

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Site Reference ID/Investigator# 107000

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety, Tolerability, and Pharmacokinetics of ABT-354 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

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