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Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Sponsor
AbbVie (Industry)
Overall Status
Terminated
CT.gov ID
NCT02220738
Collaborator
(none)
19
Enrollment
4
Locations
2
Arms
18
Duration (Months)
4.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multiple-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: ABT-957

ABT-957 administered twice-daily for 7 days

Drug: ABT-957
ABT-957 administered twice-daily for 7 days
Placebo Comparator: Placebo

Placebo administered twice-daily for 7 days

Other: Placebo for ABT-957
Placebo for ABT-957 administered twice-daily for 7 days

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetic evaluation of the two ABT-957 diastereomers [Day 7]

    maximum observed plasma concentration (Cmax), time to Cmax (peak time, Tmax), plasma concentration at the end of the dosing interval (Ctrough), the area under the plasma concentration-time curve (AUC) during each dosing interval (AUC0-12 and AUC12-24)

  2. Number of subjects with adverse events [Routinely for the duration of the study, about 7 months]

    Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 (AD);

  • Has a Mini-Mental State Examination total score of 16 to 26;

  • Has a Modified Hachinski Ischemia Scale score of ≤ 4;

  • Is taking a stable dose of donepezil, galantamine or rivastigmine for at least 30 days;

  • Has had a computerized tomography or magnetic resonance imaging. The scan must not show evidence for an alternative etiology for dementia;

  • With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, is in general good health.

Exclusion Criteria:

  • Positive screen for drugs of abuse, alcohol or cotinine;

  • Females must not have positive results for pregnancy;

  • Focal neurological signs on examination;

  • Has a clinically significant abnormal value, in serum chemistry, hematology or urinalysis;

  • History of any significant neurologic disease other than AD;

  • History of head trauma, motor vehicle accident, concussion.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Site Reference ID/Investigator# 129545 Glendale California United States 91206
2 Site Reference ID/Investigator# 129435 Orlando Florida United States 32806
3 Site Reference ID/Investigator# 129641 New York New York United States 10019
4 Site Reference ID/Investigator# 144825 Salt Lake City Utah United States 84106

Sponsors and Collaborators

  • AbbVie

Investigators

  • Study Director: Nuno Mendonca, MD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT02220738
Other Study ID Numbers:
  • M13-334
First Posted:
Aug 20, 2014
Last Update Posted:
Jul 6, 2021
Last Verified:
Jul 1, 2021
Keywords provided by AbbVie
Alzheimer's Disease
Additional relevant MeSH terms:
Alzheimer Disease

Study Results

No Results Posted as of Jul 6, 2021