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CompletedNCT01908010Updated Dec 11, 2013

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

A Phase 1 interventional study of ABT-354 and ABT-354 in Alzheimer's Disease, sponsored by AbbVie. Completed at 3 sites in United States. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-12-11.

Sponsored by AbbVie · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
55 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Alzheimer's Disease

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Keywords

  • Alzheimer's disease
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 20 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
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
  • 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Group 1, low dose

    ABT-354

    Drug: ABT-354 · Drug: Placebo

  • Experimental
    Group 2, high dose

    ABT-354

    Drug: ABT-354 · Drug: Placebo

Interventions

  • DrugABT-354

    ABT-354 Low Dose

  • DrugABT-354

    ABT-354 High Dose

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Vital signs

    Time frame: Up to Day 10

  2. ECG (electrocardiogram)

    Time frame: Up to Day 10

  3. Neurological exam

    Time frame: Up to Day 10

  4. Laboratory tests

    Hematology, Chemistry, Urinalysis

    Time frame: Up to Day 10

  5. Number of subject with adverse events

    Time frame: Up to Day 10

  6. C-SSRS (Columbia-Suicide Severity Rating Scale)

    Time frame: Up to Day 10

Secondary outcomes

  1. Pharmacokinetic parameters

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

    Time frame: Up to Day 10

07

Study locations

3 sites
  • Site Reference ID/Investigator# 106999
    Miami, Florida 33169, United States
  • Site Reference ID/Investigator# 106998
    Orlando, Florida 32806, United States
  • Site Reference ID/Investigator# 107000
    Overland Park, Kansas 66212, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01908010
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Jul 25, 2013
Start date
Jul 2013
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Dec 11, 2013

Study contacts

Gerard Marek, MD
study director · AbbVie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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