← Trials/Trial dossier/NCT01908010

CompletedPhase 1

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

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

Lead sponsor

AbbVie

Asset

ABT-354

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 16-26•AD symptomatic therapy: stable

Primary endpoints

•Vital signs•ECG (electrocardiogram)•Neurological exam

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDM13-080

NCT IDNCT01908010

Timeline

Milestones

Study start2013-07 (month precision)

Study first posted2013-07-25estimated

Primary completion2013-11actual (month precision)

Study completion2013-11actual (month precision)

Last update posted2013-12-11estimated

Assets

Drug assets

ABT-354

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Vital signs

Time frame:Up to Day 10

descriptive

Primary/protocol endpoint

ECG (electrocardiogram)

Time frame:Up to Day 10

descriptive

Primary/protocol endpoint

Number of subject with adverse events

Time frame:Up to Day 10

event count, event

Secondary/protocol endpoint

Pharmacokinetic parameters

Time frame:Up to Day 10

concentration, descriptive

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Neurological exam

Time frame:Up to Day 10

descriptive

Primary/protocol endpoint/low confidence

Laboratory tests

Time frame:Up to Day 10

descriptive

Primary/protocol endpoint/low confidence

C-SSRS (Columbia-Suicide Severity Rating Scale)

Time frame:Up to Day 10

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.