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Alzheimer's DiseasePhase 2NCT01549834

Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

A Phase 2 study testing ABT-126 in people with Alzheimer's Disease, run by AbbVie (prior sponsor, Abbott) at 43 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial summary

This is an efficacy and safety study evaluating a new treatment for subjects with mild to moderate Alzheimer's disease. 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-126
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
434 participants
Where
43 sitesin 7 countries
Study dates
Mar 2012to Oct 2013
Phase
Phase 2
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

  • The subject and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject.
  • The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1. Main Inclusion (Continued):
  • The subject meets the Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD.
  • The subject must be receiving a stable dose of an AChEI (donepezil or rivastigmine) for at least 90 days prior to Screening Visit 1.
  • The subject has a Mini-Mental Status Examination (MMSE) total score of 12 to 24, inclusive, at Screening Visit 1.
  • The subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1.
Show all 9Show fewer
  • The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening Visit 1.
  • With the exception of a diagnosis of mild-to-moderate Alzheimer's disease and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
  • The subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study.

Who cannot join

  • The subject has taken galantamine or memantine within 60 days prior to Screening Visit 1.
  • The subject has received excluded concomitant medications.
  • The subject has clinically significant abnormal laboratory values at Screening Visit 1 as determined by the investigator.
  • The subject has a history of any significant neurologic disease other than Alzheimer's disease including Parkinson's disease, multi-infarct or vascular dementia, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, any seizures, mental retardation or a history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
  • In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.

Trial locations and contacts

43 sites in 7 countries.

43 sites in 7 countries

United States11 sites

  • Site Reference ID/Investigator# 66523

    Bennington, Vermont, 05201

  • Site Reference ID/Investigator# 66522

    Delray Beach, Florida, 33445

  • Site Reference ID/Investigator# 66526

    Elk Grove Village, Illinois, 60007

  • Site Reference ID/Investigator# 66528

    Fresno, California, 93720

  • Site Reference ID/Investigator# 66530

    Hamden, Connecticut, 06518

  • Site Reference ID/Investigator# 69602

    Long Beach, California, 90806

  • Site Reference ID/Investigator# 66524

    Orlando, Florida, 32806

  • Site Reference ID/Investigator# 66527

    San Francisco, California, 94109-4841

  • Site Reference ID/Investigator# 66525

    Staten Island, New York, 10312

  • Site Reference ID/Investigator# 66531

    Tampa, Florida, 33613

  • Site Reference ID/Investigator# 66529

    West Palm Beach, Florida, 33407

Other trials in United States

Germany6 sites

  • Site Reference ID/Investigator# 68768

    Berlin, 14050

  • Site Reference ID/Investigator# 68764

    Freiburg im Breisgau, 79106

  • Site Reference ID/Investigator# 68767

    Hüttenberg, 35625

  • Site Reference ID/Investigator# 69960

    Mittweida, 09648

  • Site Reference ID/Investigator# 68765

    Munich, 81675

  • Site Reference ID/Investigator# 69959

    Schwerin, 19053

Other trials in Germany

Greece6 sites

  • Site Reference ID/Investigator# 68730

    Athens, 115 21

  • Site Reference ID/Investigator# 68732

    Athens, 151 25

  • Site Reference ID/Investigator# 68733

    Athens, 15123

  • Site Reference ID/Investigator# 68731

    Haidari, Athens, 12462

  • Site Reference ID/Investigator# 68729

    Thessaloniki, 56403

  • Site Reference ID/Investigator# 68735

    Thessaloniki, 570 10

Other trials in Greece

Canada5 sites

  • Site Reference ID/Investigator# 71793

    Gatineau, J9A 1K7

  • Site Reference ID/Investigator# 71794

    Montreal, H3T 1E2

  • Site Reference ID/Investigator# 71798

    Peterborough, K9H 2P4

  • Site Reference ID/Investigator# 71795

    Toronto, M3B 2S7

  • Site Reference ID/Investigator# 71796

    Verdun, H4H 1R3

Other trials in Canada

France5 sites

  • Site Reference ID/Investigator# 71573

    Dijon, 21033

  • Site Reference ID/Investigator# 77833

    Limoges, 87042

  • Site Reference ID/Investigator# 68706

    Paris, 75013

  • Site Reference ID/Investigator# 68704

    Paris, 75475

  • Site Reference ID/Investigator# 68705

    Toulouse, 31059

Other trials in France

South Africa5 sites

  • Site Reference ID/Investigator# 67586

    Belville, 7530

  • Site Reference ID/Investigator# 67582

    Cape Town, 7405

  • Site Reference ID/Investigator# 67584

    George, 6529

  • Site Reference ID/Investigator# 67585

    Johannesburg, 2196

  • Site Reference ID/Investigator# 67583

    Rosebank, 2196

Other trials in South Africa

United Kingdom5 sites

  • Site Reference ID/Investigator# 67787

    Bath, BA1 3NG

  • Site Reference ID/Investigator# 67784

    Glasgow, G20 0XA

  • Site Reference ID/Investigator# 67786

    London, TW8 8DS

  • Site Reference ID/Investigator# 67785

    Manchester, M8 5RB

  • Site Reference ID/Investigator# 67783

    Warrington, WA2 8WA

Other trials in United Kingdom

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

This is an efficacy and safety study evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.

Read the detailed description

This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 420 adults with mild to moderate Alzheimer's disease who are taking stable doses of acetylcholinesterase inhibitors. Subjects will be randomized to one of two ABT-126 dose arms or placebo for a 24-week treatment period.

Being tested
ABT-126, placebo
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-126Drug

    Low Dose

  • ABT-126Drug

    High Dose

  • placeboDrug

    Placebo

Study groups in NCT01549834
Study groupRoleWhat they receive
ABT-126 Low DoseExperimentallow dose
Receives: Drug: ABT-126
ABT-126 High DoseExperimentalhigh dose
Receives: Drug: ABT-126
sugar pillPlacebo comparatorPlacebo
Receives: Drug: placebo

What is being measured

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

  1. Alzheimer's Disease Assessment Scale - cognitive subscale

    An assessment tool which focuses on cognitive function and memory

    Measured: Measurements up through 24 weeks

Secondary outcomes (9)

  1. Mini Mental Status Exam

    Questionnaire which provides a quantitative measure of cognition

    Measured: Measurements up through 24 weeks

  2. Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

    Caregiver-based assessment of activities of daily living

    Measured: Measurements up through 24 weeks

  3. DEMentia Quality of Life (DEMQOL)

    Health-related quality of life measurement tool

    Measured: Measurements up through 24 weeks

  4. Clinician Interview-Based Impression of Change - plus (CIBIC-plus)

    Measures a global impression of change in severity of dementia

    Measured: Measurements up through 24 weeks

  5. Neuropsychiatry Inventory (NPI)

    Assesses the presence of psychopathology in subjects with Alzheimer's disease and other dementias

    Measured: Measurements up through 24 weeks

  6. Partner-Patient Questionnaire for Shared Activities (PPQSA)

    Measures the extent to which mood and mental state interferes with the patient-partner relationship

    Measured: Measurements up through 24 weeks

  7. Resource Use in Dementia (RUD-Lite)

    Brief measurement tool for resource utilization

    Measured: Measurements up through 24 weeks

  8. EuroQol-5D Questionnaires

    Assesses patient's mobility, self-care, usual activity, pain/discomfort and anxiety/depression

    Measured: Measurements up through 24 weeks

  9. Wechsler Memory Scale-III (WMS-III) Working Memory Index

    Assesses working memory

    Measured: Measurements up through 18 weeks

Timeline

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

  1. First posted9 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionOct 2013
  4. Study completionOct 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
434 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01549834
Sponsor's protocol ID
M11-793
Other IDs
2011-004849-40
Status last verified
Oct 2014
First submitted
7 Mar 2012
Last updated
31 Oct 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Florian H, Meier A, Gauthier S, Lipschitz S, Lin Y, Tang Q, Othman AA, Robieson WZ, Gault LM. Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978.

    PubMed 26967214

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-126 in people with Alzheimer's Disease, run by AbbVie (prior sponsor, Abbott) at 43 sites in 7 countries.

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 9 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 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Germany, Greece, Canada, France and 2 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Alzheimer's Disease Assessment Scale - cognitive subscale (time frame: Measurements up through 24 weeks). 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 NCT01549834, which also lists 1 linked publication.

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 31 Oct 2014.

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