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Alzheimer's DiseasePhase 1NCT01908010

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 study testing ABT-354 in people with Alzheimer's Disease, run by AbbVie at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 55 to 90 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
ABT-354
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
3 sitesUnited States
Study dates
Jul 2013to Nov 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Site Reference ID/Investigator# 106999

    Miami, Florida, 33169

  • Site Reference ID/Investigator# 106998

    Orlando, Florida, 32806

  • Site Reference ID/Investigator# 107000

    Overland Park, Kansas, 66212

Other trials in United States

About this study

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

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.

Being tested
ABT-354, Placebo
Keywords
Alzheimer's disease
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-354Drug

    ABT-354 Low Dose

  • ABT-354Drug

    ABT-354 High Dose

  • PlaceboDrug

    Placebo

Study groups in NCT01908010
Study groupRoleWhat they receive
Group 1, low doseExperimentalABT-354
Receives: Drug: ABT-354; Drug: Placebo
Group 2, high doseExperimentalABT-354
Receives: Drug: ABT-354; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vital signs

    Measured: Up to Day 10

  2. ECG (electrocardiogram)

    Measured: Up to Day 10

  3. Neurological exam

    Measured: Up to Day 10

  4. Laboratory tests

    Hematology, Chemistry, Urinalysis

    Measured: Up to Day 10

  5. Number of subject with adverse events

    Measured: Up to Day 10

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

    Measured: Up to Day 10

Secondary outcomes (1)

  1. Pharmacokinetic parameters

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

    Measured: Up to Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01908010
Sponsor's protocol ID
M13-080
Status last verified
Dec 2013
First submitted
23 Jul 2013
Last updated
11 Dec 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABT-354 in people with Alzheimer's Disease, run by AbbVie at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vital signs (time frame: Up to Day 10). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01908010.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.

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