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Alzheimer DiseasePhase 2NCT00479557

Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

A Phase 2 study testing ACC-001 + QS-21, ACC-001 and QS-21 in people with Alzheimer Disease, run by Pfizer at 24 sites in 3 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

To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
ACC-001 + QS-21, ACC-001 and QS-21
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
24 sitesin 3 countries
Study dates
May 2007to Jan 2013
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26)
  • Brain MRI consistent with Alzheimer Disease
  • Concurent use of Chloniesterase inhibitor or memantine allowed if stable
  • Other inclusion criteria apply

Who cannot join

  • Significant Neurological Disease other than Alzheimer's disease
  • Major psychiatric disorder
  • Contraindication to undergo brain MRI
  • Clinically significant systemic illness
  • Other exclusion criteria apply

Trial locations and contacts

24 sites in 3 countries.

24 sites in 3 countries

France12 sites

  • Hopital Pellegrin-Centre Mémoire de Recherche et de Ressources

    Bordeaux, 33076

  • CHRU de Lille

    Lille, 59037

  • CHRU de Lille

    Lille (mri), 59037

  • Hôpital Sainte-Marguerite

    Marseille, 13385

  • CHU Hôpital Gui de Chaulliac

    Montpellier, 34295

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, Cedex 13 (mri), 75651

  • Hôpital Pitié-Salpétrière

    Paris, Paris, 75651

  • Groupe Hospitalier Broca-La Rochefoucauld

    Paris, 75013

  • Clinique de L'Union

    St.-Jean, 31240

  • Hôpital LA GRAVE

    Toulouse, 31059

  • Chru Purpan

    Toulouse, 31300

  • Clinique PASTEUR

    Toulouse, 31300

Other trials in France

Germany8 sites

  • Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin

    Berlin, 14050

  • Zentralinstitut fuer Seelische Gesundheit

    Frankenthal, 67227

  • Unversitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Klinik fuer Psychiatrie und Psychotherapie

    Göttingen, 37075

  • Zentralinstitut fuer Seelische Gesundheit

    Mannheim, 68159

  • Technische Universitaet Muenchen, Klinikum rechts der Isar

    München, 81675

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Universitaetsklinikum Muenster

    Münster, 48165

Other trials in Germany

Spain4 sites

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital Clinico y Provincial

    Barcelona, Barcelona, 08036

  • Hospital Universitario Clinico San Carlos

    Madrid, Madrid, 28040

Other trials in Spain

About this study

Official title: A Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer's Disease

To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.

Being tested
ACC-001 + QS-21, ACC-001, QS-21, Placebo: Phosphate buffered saline
Keywords
Alzheimer's Disease, active immunization
Medical subject headings
Alzheimer Disease

What participants receive

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

  • ACC-001 + QS-21Biological

    Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12

  • ACC-001Biological

    Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12

  • QS-21Biological

    QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12

  • Placebo: Phosphate buffered salineDrug

    Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12

Study groups in NCT00479557
Study groupRoleWhat they receive
1Active comparatorarm 1: ACC-001 (Vanutide Cridificar)+ QS-21
Receives: Biological: ACC-001 + QS-21
2Active comparatorarm 2: ACC-001
Receives: Biological: ACC-001
3Placebo comparatorarm 3: QS-21
Receives: Biological: QS-21
4Placebo comparatorDrug: Phosphate Buffered Saline (PBS)
Receives: Drug: Placebo: Phosphate buffered saline

What is being measured

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

  1. Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)

    An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Measured: approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.

Secondary outcomes (3)

  1. Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

    The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.

    Measured: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

  2. GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

    The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.

    Measured: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

  3. Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)

    IgG subtypes were not assessed

    Measured: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

Timeline

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

  1. First posted28 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionJan 2013
  4. Study completionJan 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00479557
Sponsor's protocol ID
3134K1-200
Other IDs
B2571004, 2006-002061-39
Status last verified
Nov 2015
First submitted
24 May 2007
Last updated
1 Jan 2016
Data monitoring committee
Yes

Publications

  • Pasquier F, Sadowsky C, Holstein A, Leterme Gle P, Peng Y, Jackson N, Fox NC, Ketter N, Liu E, Ryan JM; ACC-001 (QS-21) Study Team. Two Phase 2 Multiple Ascending-Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2016;51(4):1131-43. doi: 10.3233/JAD-150376.

    PubMed 26967206

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ACC-001 + QS-21, ACC-001 and QS-21 in people with Alzheimer Disease, run by Pfizer at 24 sites in 3 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 4 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 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France, Germany, 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. 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?

Yes. Results are posted in the registry (first posted 1 Jan 2016). 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 Treatment-emergent AEs or Serious Adverse Events (SAEs) (time frame: approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.). 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 NCT00479557, 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 1 Jan 2016.

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