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

NCT01908010 | Completed Phase 1

• 1 other identifier: M13-080
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease

Outcome Measures

Primary Outcomes (6)

• Vital signs

  Up to Day 10

• ECG (electrocardiogram)

  Up to Day 10

• Neurological exam

  Up to Day 10

• Laboratory tests

  Hematology, Chemistry, Urinalysis

  Up to Day 10

• Number of subject with adverse events

  Up to Day 10

• C-SSRS (Columbia-Suicide Severity Rating Scale)

  Up to Day 10

Secondary Outcomes (1)

• Pharmacokinetic parameters

  Up to Day 10

Study Arms (2)

Group 1, low dose

EXPERIMENTAL

ABT-354

Drug: ABT-354; Drug: Placebo

Group 2, high dose

EXPERIMENTAL

ABT-354

Drug: ABT-354; Drug: Placebo

Interventions

ABT-354 DRUG

ABT-354 Low Dose

Group 1, low dose

Placebo DRUG

Placebo

Group 1, low dose; Group 2, high dose

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

Site Reference ID/Investigator# 106999

Miami, Florida, 33169, United States

Location

Site Reference ID/Investigator# 106998

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 107000

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Gerard Marek, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 25, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

US (3)