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Alzheimer's DiseasePhase 2NCT01723826

A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab

A Phase 2 study testing Crenezumab in people with Alzheimer's Disease, run by Genentech, Inc. at 86 sites in 6 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 Phase II, open-label extension (OLE), multicenter study will evaluate the long-term safety and tolerability of crenezumab in participants with mild to moderate Alzheimer's disease who have participated in and completed the treatment period of the Phase II Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Crenezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
86 sitesin 6 countries
Study dates
7 Dec 2012to 8 Feb 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Previous participation in Study ABE4869g or ABE4955g and completion of the Week 73 visit
  • Adequate visual and auditory acuity, in the investigator's judgment, to allow for neuropsychological testing
  • Availability of a person ("caregiver") who can provide information on activities of daily living and behavior in order to complete the study-specific assessments
  • Diagnosis of probable Alzheimer's disease according to the National Institute on Neurological and Communication Disease and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria (McKhann et al. 1984)
  • Mini-Mental State Examination (MMSE) score of 10 or more at screening (Folstein et al. 1975)
  • For male participants with partners with reproductive potential, agreement to use a reliable means of contraception (e.g., condoms) during the study and for at least 8 weeks following the last dose of study drug
  • For female participants, a negative pregnancy test at screening

Who cannot join

  • Early treatment and/or study discontinuation prior to completion of the Week 73 visit of Genentech Study ABE4869g or ABE4955g
  • Early discontinuation from the treatment schedule of a prior version of Study GN28525 for safety reasons. If treatment discontinuation occurred for safety reasons, participants may not re-start dosing on extended treatment schedules offered in amendments to Study GN28525
  • Inability to tolerate Magnetic Resonance Imaging (MRI) procedures or contraindication to MRI
  • Female participants with reproductive potential: Female participants must either have undergone documented surgical sterilization or have not experienced menstruation for at least 12 consecutive months
  • Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the participant'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
Show all 26Show fewer
  • History of severe, clinically significant central nervous system trauma
  • History or presence of clinically relevant intracranial tumor
  • Presence of infections that affect the brain function or history of infections that resulted in neurologic sequelae
  • History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease
  • History or presence of a neurologic disease other than Alzheimer's disease that may affect cognition
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
  • Evidence of malignancies (except squamous cell cancer or basal cell cancer of the skin), acute infections, renal failure that requires dialysis, or other unstable medical disease not related to Alzheimer's disease that, in the investigator's opinion, would preclude participant's participation. Cancer that is not being actively treated with anti-cancer therapy or radiotherapy as well as cancers which are considered to have low probability of recurrence are allowed
  • History or presence of atrial fibrillation that, in the investigator's judgment, poses a risk for future stroke
  • Chronic kidney disease of Stage greater than or equal to (>=) 4, according to the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI) guidelines for chronic kidney disease (CKD)
  • Impaired hepatic function
  • Impaired coagulation (activated partial thromboplastin time [aPTT] greater than [>] 1.2 times upper limit of normal [ULN])
  • Platelet count less than (<) 100,000 per microliter (mcL)
  • Presence at screening of superficial siderosis of central nervous system, more than 8 cerebral microhemorrhages, or evidence of a prior cerebral macrohemorrhage
  • Presence at screening of any other significant cerebral abnormalities, including ARIA-E
  • Treatment with anticoagulation medications within 2 weeks prior to enrollment. Clopidogrel, dipyridamole, and aspirin are permitted
  • Treatment with anticholinergic antidepressants, typical antipsychotics, or barbiturates within 2 weeks prior to enrollment. All other antidepressants and atypical antipsychotics are allowed with certain restrictions as defined in the protocol
  • Chronic use of opiates, opioids, or benzodiazepines
  • Any biologic therapy within 75 weeks prior to enrollment
  • Any investigational agent (other than crenezumab) within 75 weeks prior to enrollment
  • Treatment with anticholinergic antidepressants, typical antipsychotics, barbiturates, or narcotics within 5 half-lives or 3 months prior to screening, whichever is longer. All other antidepressants and atypical antipsychotics are allowed. Chronic use of benzodiazepines is not allowed; however, the intermittent use of benzodiazepines is allowed, except within 2 days prior to any neurocognitive assessment

Trial locations and contacts

86 sites in 6 countries.

86 sites in 6 countries

United States47 sites

  • 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

  • Dekalb Neurology Associates

    Decatur, Georgia, 30033

  • Brain Matters Research, Inc.

    Delray Beach, Florida, 33445

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • Memory Enhancement Center of America, Inc.

    Eatontown, New Jersey, 07724

  • Alexian Brothers Neurosci Inst

    Elk Grove Village, Illinois, 60007

  • Pharmacology Research Inst

    Encino, California, 91316

  • Margolin Brain Institute

    Fresno, California, 93720

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

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

    Houston, Texas, 77030

  • Indiana Univ School of Med

    Indianapolis, Indiana, 46202

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

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

    La Jolla, California, 92037

  • Cleveland Clinic Lou Ruvo; Center for Brain Research

    Las Vegas, Nevada, 89106

  • Empire Neurology, PC

    Latham, New York, 12210

  • USC School of Medicine

    Los Angeles, California, 90033

  • University of California Los Angeles (UCLA)

    Los Angeles, California, 90095

  • Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.

    Manhasset, New York, 11030

  • Miami Jewish Health Systems; Clinical Research

    Miami, Florida, 33137

  • NeuroCognitive Institute

    Mount Arlington, New Jersey, 07856

  • Collier Neurologic Specialists

    Naples, Florida, 34105

  • 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

  • Bioclinica Research

    Orlando, Florida, 32806

  • Pacific Neuroscience Med Grp

    Oxnard, California, 93030

  • Stanford Univ Medical Center

    Palo Alto, California, 94304

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Summit Research Network Inc.

    Portland, Oregon, 97210

  • Butler Hospital

    Providence, Rhode Island, 02906

  • 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

  • Redwood Regional Medical Group

    Santa Rosa, California, 95403

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Millennium Psychiatric Associates, LLC

    St Louis, Missouri, 63132

  • Banner Sun Health Research Insitute

    Sun City, Arizona, 85351

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

Other trials in United States

Canada13 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

  • St. Joseph's HC-Parkwood Hosp

    London, Ontario, N6C 5J1

  • Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique

    Montreal, Quebec, H1T 2M4

  • Bruyere Continuing Care

    Ottawa, Ontario, K1N 5C8

  • Kawartha Centre - Redefining Healthy Aging

    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

United Kingdom8 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

  • 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

France6 sites

  • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

    Bron, 69677

  • CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique

    Limoges, 87042

  • Hopital Central; Neurologie

    Nancy, 54035

  • Hopital Nord Laennec

    Nantes, 44093

  • CHU de Rouen Hopital; Service de Neurologie

    Rouen, 76031

  • Hôpital Civil de Strasbourg

    Strasbourg, 67091

Other trials in France

Germany6 sites

  • Univ Berlin; Klin fur Psychi & Psycho Charite

    Berlin, 12203

  • Bezirkskrankenhaus Günzburg

    Günzburg, 89312

  • Zentralinstitut fuer Seelische Gesundheit

    Mannheim, 68159

  • Ludwig-Maximilians-Univ.

    München, 81377

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Universitätsklinik Tübingen; Psychiatrie und Psychotherapie

    Tübingen, 72076

Other trials in Germany

Spain6 sites

  • Complejo Hospitalario Universitario de Albacete

    Albacete, 2006

  • Hospital de Cruces; Servicio de Neurologia

    Barakaldo, Vizcaya, 48903

  • Fundació ACE

    BArcelon, Barcelona, 08034

  • 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

Other trials in Spain

About this study

Official title: A Multicenter, Open-Label, Long-Term Safety Extension of Phase II Studies ABE4869g and ABE4955g in Patients With Mild to Moderate Alzheimer's Disease

This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term safety and tolerability of crenezumab in participants with mild to moderate Alzheimer's disease who have participated in and completed the treatment period of the Phase II Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time on study treatment is 144 weeks.

Being tested
Crenezumab
Medical subject headings
Alzheimer Disease

What participants receive

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

  • CrenezumabDrug

    Also called RO5490245

    Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.

Study groups in NCT01723826
Study groupRoleWhat they receive
CrenezumabExperimentalParticipants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
Receives: Drug: Crenezumab

What is being measured

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

  1. Percentage of Participants With Adverse Events (AEs)

    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. . An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Measured: Up to 50 months

  2. Percentage of Participants by Nature of AEs

    A serious adverse event (SAE) is any AE that meets any of the following criteria: fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in a neonate/infant. Non-SAE of special interest for this study include the following: cerebral vascular edema, Superficial siderosis of central nervous system, cerebral micro-hemorrhages or macro-hemorrhages, pneumonia, liver injury.

    Measured: Up to 50 months

  3. Percentage of Participants by Severity of AEs

    AE severity grading scale for the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 was used for assessing adverse event severity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on the following general guideline: Grade 1) mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2) moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3) severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4) life-threatening consequences; urgent intervention indicated, Grade 5) death related to AE.

    Measured: Up to 50 months

  4. Percentage of Participants With Human Anti-Therapeutic Antibody (ATA) Formation

    ATA is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy. Percentage of participants at post-baseline with positive results for ATA against crenezumab are reported.

    Measured: Pre-dose (Day-14), predose at Week 25, 49, 97, Follow-up Week 8 (Week 153) and 12 (Week 157)

  5. Percentage of Participants With Amyloid-Related Imaging Abnormalities Edema/Effusions (ARIA-E)

    Alzheimer's disease (AD) is associated with ARIA. The occurrence of imaging abnormalities believed to represent cerebral vasogenic edema, has been reported in association with the investigational use of compounds that are intended to treat Alzheimer's disease by reducing Abeta in the brain. Here, the percentage of participants with symptomatic and asymptomatic ARIA-E were reported.

    Measured: Baseline, Weeks 23, 47, 71, 97, 121 and 153

  6. Percentage of Participants With Amyloid-Related Imaging Abnormalities-Hemorrhage (ARIA-H)

    AD is associated with ARIA. Cerebral micro-hemorrhages (microbleeds [MBs]) are radiologically defined as small dot-like foci of signal loss observed on magnetic resonance imaging (MRI) sequences sensitive for paramagnetic tissue properties. The occurrence of MBs has also been identified as an adverse event in anti-amyloid vaccination trials, and together with superficial siderosis, they have been termed ARIA-H.

    Measured: Baseline, Weeks 23, 47, 71, 97, 121 and 153

Timeline

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

  1. First posted8 Nov 2012 (estimated)
  2. Study start7 Dec 2012
  3. Primary completion8 Feb 2017
  4. Study completion8 Feb 2017

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01723826
Sponsor's protocol ID
GN28525
Other IDs
2012-003242-33
Status last verified
Feb 2020
First submitted
6 Nov 2012
Last updated
20 Feb 2020
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Crenezumab in people with Alzheimer's Disease, run by Genentech, Inc. at 86 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 7 inclusion and 26 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 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Canada, United Kingdom, France, Germany 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. 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?

Yes. Results are posted in the registry (first posted 12 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Adverse Events (AEs) (time frame: Up to 50 months). 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 NCT01723826.

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 20 Feb 2020.

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Clinical Trial NCT01723826 | AzTrials