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Alzheimer's DiseasePhase 2NCT01343966

A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)

A Phase 2 study testing MABT5102A in people with Alzheimer's Disease, run by Genentech, Inc. at 92 sites in 6 countries.

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 is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's Disease. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
MABT5102A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
448 participants
Where
92 sitesin 6 countries
Study dates
30 Apr 2011to 28 Feb 2014
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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) criteria
  • Mini-Mental State Examination (MMSE) score of 18-26 points at screening
  • Geriatric Depression Scale (GDS-15) score of < 6
  • Completion of 6 years of education (or good work history consistent with exclusion of mental retardation or other pervasive developmental disorders)
  • If receiving concurrent AD treatment, patient must be on the medication for at least 3 months at a stable dose for at least 2 months prior to randomization.

Who cannot join

  • Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care
  • History or presence of clinically evident vascular disease potentially affecting the brain
  • History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma
  • Hospitalization within 4 weeks prior to screening
  • Previous treatment with MABT5102A or any other therapeutic that targets Abeta
  • Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, with the exception of routinely recommended vaccinations, which are allowed

Trial locations and contacts

92 sites in 6 countries.

92 sites in 6 countries

United States40 sites

  • Albany Medical College

    Albany, New York, 12208

  • Clinical Neuroscience Research Associates, Inc.

    Bennington, Vermont, 05201

  • Florida Atlantic University; College of Medicine

    Boca Raton, Florida, 33431

  • Meridien Research

    Brooksville, Florida, 34601

  • Rush Alzheimer's Disease Cntr.

    Chicago, Illinois, 60612

  • Millennium Psychiatric Associates, LLC

    Creve Coeur, Missouri, 63141

  • Brain Matters Research, Inc.

    Delray Beach, Florida, 33445

  • Alexian Brothers Neurosci Inst

    Elk Grove Village, Illinois, 60007

  • Pharmacology Research Inst

    Encino, California, 91316

  • Clinical Trials of America, Inc.

    Eugene, Oregon, 97401

  • Margolin Brain Institute

    Fresno, California, 93720

  • Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine

    Houston, Texas, 77030

  • IU Healthy Partners Adult Neurology Clinic

    Indianapolis, Indiana, 46202

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • Univ of CA San Diego; Neurosciences Comp.Alzheimer's

    La Jolla, California, 92037

  • Empire Neurology, PC

    Latham, New York, 12210

  • USC School of Medicine

    Los Angeles, California, 90033

  • Miami Jewish Health Systems; Clinical Research

    Miami, Florida, 33137

  • NeuroCognitive Institute

    Mount Arlington, New Jersey, 07856

  • Collier Neurologic Specialists

    Naples, Florida, 34102

  • Yale University

    New Haven, Connecticut, 06511

  • Louisiana Research Associates

    New Orleans, Louisiana, 70114

  • Columbia University Medical Center

    New York, New York, 10032

  • Pharmacology Research Inst

    Newport Beach, California, 92660

  • Medical Uni of South Carolina

    North Charleston, South Carolina, 29425

  • Compass Research

    Orlando, Florida, 32806

  • Hope Research Institute

    Phoenix, Arizona, 85050

  • Summit Research Network Inc.

    Portland, Oregon, 97210

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607-6520

  • University of Rochester Medical Center; Monroe Community Hospital

    Rochester, New York, 14627

  • Investigational Drug Service; Univ of Rochester Medical Ctr

    Rochester, New York, 14642

  • University of California Davis Medical System

    Sacramento, California, 95817

  • Pacific Research Network - PRN

    San Diego, California, 92103

  • Uni of California San Francisco

    San Francisco, California, 94117

  • Neurological Research Inst

    Santa Monica, California, 90025

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • Neurology & Neuroscience Ctr of Ohio

    Toledo, Ohio, 43623

  • Memory Enhancement Center of NJ, Inc.

    Toms River, New Jersey, 08755

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

Other trials in United States

Canada16 sites

  • Jbn Medical Diagnostic Services Inc.

    Burlington, Ontario, L7M 4Y1

  • Clinique Neuro Rive-Sud

    Greenfield Park, Quebec, J4V 2J2

  • Capitol District Health Authority

    Halilfax, Nova Scotia, B3H 2E1

  • The Med Arts Health Rsrch Grp

    Kelowna, British Columbia, V1Y 3G8

  • Hotel Dieu Hospital

    Kingston, Ontario, K7L 2V7

  • Providence Care Centre; Mental Health Site

    Kingston, Ontario, K7L 4X3

  • St. Joseph's HC-Parkwood Hosp

    London, Ontario, N6C 5J1

  • Saibal Nandy Professional Corporation

    Medicine Hat, Alberta, T1B 4E7

  • Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique

    Montreal, Quebec, H1T 2M4

  • Bruyere Continuing Care

    Ottawa, Ontario, K1N 5C8

  • The Med Arts Health Rsrch Grp

    Penticton, British Columbia, V2A 5C8

  • Kawartha Regional Memory Clinic

    Peterborough, Ontario, K9H 2P4

  • CHAUQ Hopital Enfant-Jesus

    Québec, Quebec, G1J 1Z4

  • Toronto Memory Program (Neurology Research Inc.)

    Toronto, Ontario, M3B 2S7

  • University of British Columbia Hospital; Division of Neurology

    Vancouver, British Columbia, V6T 2B5

  • McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric

    Verdun, Quebec, H4H 1R3

Other trials in Canada

Germany11 sites

  • Studienambulanz emovis GmbH; St. Joseph Krankenhaus

    Berlin, 10626

  • Univ Berlin; Klin fur Psychi & Psycho Charite

    Berlin, 12203

  • Universitätsklinikum Erlangen; Augenklinik

    Erlangen, 91054

  • Bezirkskrankenhaus Günzburg

    Günzburg, 89312

  • Zentralinstitut fuer Seelische Gesundheit

    Mannheim, 68159

  • Inst fur Stedien zur Psych Ges

    Mannheim, 68165

  • Psych Klin der LMU Muenchen

    München, 80336

  • Ludwig-Maximilians-Univ.

    München, 81377

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Villa Sauer, Praxis für; Neurologie und Psychiatrie

    Siegen, 57072

  • Universitätsklinik Tübingen; Psychiatrie und Psychotherapie

    Tübingen, 72076

Other trials in Germany

France9 sites

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33000

  • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

    Bron, 69677

  • Chu Limoges

    Limoges, 87042

  • Hopital Nord Laennec

    Nantes, 44093

  • Hopital de Cimiez

    Nice, 06003

  • Hopital Broca

    Paris, 75013

  • CHU de Rouen Hopital; Service de Neurologie

    Rouen, 76031

  • Hopital Hautepierre; Centre dInvestigation Clinique

    Strasbourg, 67098

  • Hôpital Casselardit; Cons memoire

    Toulouse, 31059

Other trials in France

United Kingdom9 sites

  • The Rice Centre; Royal United Hospital

    Bath, BA1 3NG

  • West London Research Unit; Brentford Lodge

    Brentford, TW8 8DS

  • Royal Sussex County Hospital, CIRU Level 5

    Brighton, BN2 5BE

  • Glasgow Memory Clinic

    Glasgow, G20 0XA

  • Camden Mews Day Hospital; Camden and Islington

    London, NW1 9DB

  • The National Hospital for Neurology & Neurosurgery; Dementia Research Center

    London, GT LON, WC1N 3BG

  • Southampton General Hospital; Pharmacy

    Southampton, SO16 6YD

  • Moorgreen Hospital; Memory Assessment & Rsch Ctr

    Southampton, SO30 3JB

  • Great Western Hosp.; Kingshill Research Ctr

    Swindon, SN3 6BW

Other trials in United Kingdom

Spain7 sites

  • Hospital Perpetuo Socorro

    Albacete, 02006

  • Hospital de Cruces; Servicio de Neurologia

    Barakaldo, Vizcaya, 48903

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Policlinica Guipuzcoa

    Donostia / San Sebastian, Guipuzcoa, 20009

  • Clinica Ruber, 4 planta; Servicio de Neurologia

    Madrid, 28006

  • Hospital General de Catalunya

    San Cugat Del Valles, Barcelona, 08195

  • Hospital Universitario Virgen de la Macarena;

    Seville, 41071

Other trials in Spain

About this study

Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)

This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's Disease.

Being tested
MABT5102A, 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.

  • MABT5102ADrug

    Repeating subcutaneous injection

  • MABT5102ADrug

    Repeating intravenous infusion

  • placeboDrug

    Repeating subcutaneous injection

  • placeboDrug

    Repeating intravenous infusion

Study groups in NCT01343966
Study groupRoleWhat they receive
Part 1: Subcutaneous cohort expExperimentalNot described
Receives: Drug: MABT5102A
Part 2: Intravenous cohort expExperimentalNot described
Receives: Drug: MABT5102A
Part 1: Subcutaneous cohortPlacebo comparatorRepeating subcutaneous injection
Receives: Drug: placebo
Part 2: Intravenous cohortPlacebo comparatorRepeating intravenous infusion
Receives: Drug: placebo

What is being measured

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

  1. Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score

    Measured: From baseline to Week 73

  2. Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score

    Measured: From baseline to Week 73

Secondary outcomes (1)

  1. Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score

    Measured: From baseline to Week 73

Timeline

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

  1. First posted28 Apr 2011 (estimated)
  2. Study start30 Apr 2011
  3. Primary completion28 Feb 2014
  4. Study completion28 Feb 2014

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
Double blind
Who is masked
Participant, Investigator
Enrolment
448 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01343966
Sponsor's protocol ID
ABE4869g
Other IDs
ABBY, GN00761
Status last verified
Jul 2017
First submitted
27 Apr 2011
Last updated
12 Jul 2017
Results posted
No

Publications

  • Polhamus DG, Dolton MJ, Rogers JA, Honigberg L, Jin JY, Quartino A. Longitudinal Exposure-Response Modeling of Multiple Indicators of Alzheimer's Disease Progression. J Prev Alzheimers Dis. 2023;10(2):212-222. doi: 10.14283/jpad.2023.13.

    PubMed 36946448

  • Yoshida K, Moein A, Bittner T, Ostrowitzki S, Lin H, Honigberg L, Jin JY, Quartino A. Pharmacokinetics and pharmacodynamic effect of crenezumab on plasma and cerebrospinal fluid beta-amyloid in patients with mild-to-moderate Alzheimer's disease. Alzheimers Res Ther. 2020 Jan 22;12(1):16. doi: 10.1186/s13195-020-0580-2.

    PubMed 31969177

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MABT5102A in people with Alzheimer's Disease, run by Genentech, Inc. at 92 sites in 6 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 5 inclusion and 6 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 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Canada, Germany, France, United Kingdom and 1 more country. 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?

Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score (time frame: From baseline to Week 73). The study lists 2 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 NCT01343966, which also lists 2 linked publications.

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 12 Jul 2017.

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