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Alzheimer's DiseasePhase 2/3AMBARNCT01561053

A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease

A Phase 2/3 study testing Albumin 5%, Albumin 20% and Immunoglobulin in people with Alzheimer's Disease, run by Instituto Grifols, S.A. at 40 sites in 2 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

The purpose of this study is to evaluate the changes in the cognitive, functional, behavioral and global domains based on the different applicable psychometric batteries and scales. Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Albumin 5%, Albumin 20% and Immunoglobulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
347 participants
Where
40 sitesin 2 countries
Study dates
19 Apr 2012to 6 Mar 2018
Phase
Phase 2/3
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 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  1. Males or females between 55-85 years of age at the time of signing of the informed consent document.
  2. A diagnosis of Alzheimer's disease (NINCDS-ADRDA criterion), and mini-mental status examination (MMSE) score between >/=18 and </=26.
  3. Current stable treatment with acetylcholine esterase inhibitors (AChEIs) and/or memantine for the previous three months.
  4. The patient and a close relative or the legal representative must read the patient information sheet, agree to participation in the trial, and then sign the informed consent document (the patient personally and the close relative/legal representative).
  5. The patient must be able to follow the study protocol, receive the treatment in the established time period, and continue during the follow-up interval.
  6. A brain computed axial tomography (CAT) or magnetic resonance imaging (MRI) study, obtained in the 12 months prior to recruitment, showing the absence of cerebrovascular disease, should be available. Nevertheless, it is mandatory to use the MRI obtained during the screening period to rule out any cerebrovascular disease.
  7. A stable care taker must be available, and must attend the patient study visits.

Main Exclusion Criteria:

  1. Any contraindication for plasma exchange due to behavioral disorders or abnormal coagulation parameters, such as for example:
  • Hypocalcemia (Ca++ < 8.7 mg/dL)
  • Thrombocytopenia (<100,000/µL)
  • Fibrinogen <1.5 g/L
  • Prothrombin time (Quick) p<60% versus control (international normalized ratio (INR) >1.5)
  • Beta-blocker treatment and bradycardia <55/min
  • Treatment with angiotension-converting enzyme inhibitors (ACEIs) (increased risk of allergic reactions)
  1. Hemoglobin < 10 g/dL
  2. Difficult venous access precluding plasma exchange.
  3. A history of frequent adverse reactions (serious or otherwise) to blood products.
  4. Hypersensitivity to albumin or allergies to any of the components of Albutein.
  5. History of immunoglobulin A (IgA) deficiency.
  6. Known allergies to Flebogamma DIF components such as sorbitol.
  7. History of thromboembolic complications of intravenous immunoglobulins.
  8. Plasma creatinine > 2 mg/dl.
  9. Uncontrolled high blood pressure (systolic blood pressure of 160 mmHg or higher and/or diastolic blood pressure of 100 mmHg or higher despite treatment during the last 3 months).
  10. Liver cirrhosis or any liver problem with glutamic pyruvic transaminase (GPT) > 2.5 x upper limit of normal (ULN), or bilirubin > 2 mg/dL.
  11. Heart diseases, as evidenced by myocardial infarction, severe or unstable angina, or heart failure (New York Association Class II, III or IV) in the past 12 months.
  12. Participation in other clinical trials, or the receipt of any other investigational drug in the three months prior to the start of the study.
  13. Any condition complicating adherence to the study protocol (illness with less than one year of expected survival, known drug or alcohol abuse, etc.).
  14. Pregnant or nursing women or women not using effective contraceptive methods for at least one month after plasma exchange.
  15. Fewer than six years of education (exclusion criteria under medical criterion).
  16. Less than three months with stable treatment for behavioral disorders or insomnia.
  17. Patients being treated with anticoagulants or antiplatelet therapy (antiaggregants) should not be recruited in the study.

Trial locations and contacts

40 sites in 2 countries.

40 sites in 2 countries

United States22 sites

  • Bradenton Research Center, Inc.

    Bradenton, Florida, 34205

  • Roper St. Francis Healthcare

    Charleston, South Carolina, 29401

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Wesley Neurology Clinic

    Cordova, Tennessee, 38018

  • Neurology Specialists Inc

    Dayton, Ohio, 45417

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Quantum Laboratories

    Deerfield Beach, Florida, 33064

  • Mountain View Clinical Research, Inc

    Denver, Colorado, 80209

  • Galiz Research, LLC

    Hialeah, Florida, 33016

  • Largo Medical Center

    Largo, Florida, 33770

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • L&L Research Choices, Inc

    Miami, Florida, 33144

  • Allied Biomedical Research Institute

    Miami, Florida, 33155

  • Miami Dade Medical Research Institute, LLC

    Miami, Florida, 33176

  • The NeuroCognitive Institute

    Mount Arlington, New Jersey, 08756

  • Neurology Associates of Osmond Beach

    Ormond Beach, Florida, 32174

  • Mid-Atlantic Geriatric/ARC

    Paterson, New Jersey, 08759

  • PharmaSeek LLC (DMI Research)

    Pinellas Park, Florida, 33782

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Northern California Research

    Sacramento, California, 95821

  • RTR Medical Group

    Savannah, Georgia, 31419

  • Howard University

    Washington D.C., District of Columbia, 20059

Other trials in United States

Spain18 sites

  • Fundació ACE

    Barcelona, 08028

  • Hospital Vall d'Hebrón

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario de Burgos

    Burgos, 09005

  • Hospital General de Elche

    Elche, Alicante, 03203

  • Hospital Universitario del Vinalopó

    Elche, Alicante, 03293

  • Hospital Universitario de Getafe

    Getafe, Madrid, 28905

  • Parc Hospitalari Martí i Julià

    Girona, 17190

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitari de Santa Maria

    Lleida, 25198

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital General de Catalunya

    Sant Cugat del Vallès, Barcelona, 08190

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, Canary Islands, 38010

  • Hospital Universitari Mútua de Terrassa

    Terrassa, Barcelona, 08221

  • Hospital Universitario Doctor Peset

    Valencia, 46017

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026

  • Hospital Viamed Montecanal

    Zaragoza, 50012

Other trials in Spain

About this study

Official title: A Multicenter, Randomized, Controlled Study To Evaluate The Efficacy and Safety of Short-Term Plasma Exchange Followed by Long-Term Plasmapheresis With Infusion of Human Albumin Combined With Intravenous Immunoglobulin In Patients With Mild-Moderate Alzheimer's Disease

The purpose of this study is to evaluate the changes in the cognitive, functional, behavioral and global domains based on the different applicable psychometric batteries and scales.

Read the detailed description

A clinical trial comprised of 350 subjects with probable mild to moderate Alzheimer's Disease (AD) will be conducted primarily to determine whether plasmapheresis with infusion of human albumin combined with intravenous immunoglobulin (IVIG) is able to modify patient's cognitive, functional, behavioral and global domains. There will be 3 treatment groups and 1 control group. The subjects will be randomized in a 1:1:1:1 proportion.

Being tested
Albumin 5%, Albumin 20%, Immunoglobulin
Keywords
Alzheimer's disease, Amyloid Beta (AB) peptide, Albumin, Intravenous immunoglobulin, IVIG
Medical subject headings
Alzheimer Disease, Plaque, Amyloid

What participants receive

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

  • Albumin 5%Biological

    Also called Albutein® 5%, Human Albumin Grifols 5%

    Therapeutic plasma exchange with human albumin 5%

  • Albumin 20%Biological

    Also called Albutein® 20%, Human Albumin Grifols 20%

    Low volume plasma exchange with human albumin 5%

  • ImmunoglobulinBiological

    Also called Flebogamma® 5% DIF

    Intravenous human immunoglobulin 5%

Study groups in NCT01561053
Study groupRoleWhat they receive
High Albumin + ImmunoglobulinExperimentalTherapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)
Receives: Biological: Albumin 5%; Biological: Albumin 20%; Biological: Immunoglobulin
Low Albumin + ImmunoglobulinExperimentalTherapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period)
Receives: Biological: Albumin 5%; Biological: Albumin 20%; Biological: Immunoglobulin
Low AlbuminExperimentalTherapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)
Receives: Biological: Albumin 5%; Biological: Albumin 20%
Control (sham) groupNo interventionSimulated plasma exchange procedure

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 (ADAS-Cog) Total Score (Changes From Baseline to 14 Months)

    ADAS-Cog total score as a change from baseline to 14 months

    The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment.

    Measured: Baseline and 14 months

  2. Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score (Changes From Baseline to 14 Months)

    ADCS-ADL total score as a change from baseline to 14 months

    The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome).

    Measured: Baseline and 14 Months

Timeline

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

  1. First posted22 Mar 2012 (estimated)
  2. Study start19 Apr 2012
  3. Primary completion6 Mar 2018
  4. Study completion6 Mar 2018

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
347 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01561053
Sponsor's protocol ID
IG1002
Acronym
AMBAR
Status last verified
Jul 2019
First submitted
16 Mar 2012
Last updated
31 Jul 2019
Data monitoring committee
No

Publications

  • Podger L, Stewart WF, Serrano D, Lipton RB, Gomez-Ulloa D, Ayasse ND, Barnes FB, Davis EA, Runken MC. Application of a Novel Endpoint Staging Framework: Proof of Concept in the AMBAR Study. J Alzheimers Dis. 2024;98(3):1079-1094. doi: 10.3233/JAD-231197.

    PubMed 38489186

  • Cuberas-Borros G, Roca I, Castell-Conesa J, Nunez L, Boada M, Lopez OL, Grifols C, Barcelo M, Pareto D, Paez A. Neuroimaging analyses from a randomized, controlled study to evaluate plasma exchange with albumin replacement in mild-to-moderate Alzheimer's disease: additional results from the AMBAR study. Eur J Nucl Med Mol Imaging. 2022 Nov;49(13):4589-4600. doi: 10.1007/s00259-022-05915-5. Epub 2022 Jul 22.

    PubMed 35867135

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Albumin 5%, Albumin 20% and Immunoglobulin in people with Alzheimer's Disease, run by Instituto Grifols, S.A. at 40 sites in 2 countries.

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

Who may be eligible to take part?

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 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Spain. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 31 Jul 2019). 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?

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score (Changes From Baseline to 14 Months) (time frame: Baseline and 14 months). 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 NCT01561053, 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 31 Jul 2019.

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