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Alzheimer's DiseasePhase 2NCT01117818

Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease

A Phase 2 study testing active: AFFITOPE AD02 in people with Alzheimer's Disease, run by Affiris AG at 31 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 multiple vaccination study to find out if it is a safe treatment and what effects it has on the symptoms of early Alzheimer's disease in male and female patients aged 50 to 80 years. Approximately 40 study sites in Europe will be involved. 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?
active: AFFITOPE AD02
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
335 participants
Where
31 sitesin 6 countries
Study dates
Sep 2010to Dec 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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent capability
  • Early AD, based on episodic memory deficit and hippocampal atrophy
  • Age from 50 to 80, inclusive
  • MMSE of 20+
  • Brain magnetic resonance imaging scan consistent with the diagnosis of AD
  • Stable doses of medications (cholinesterase inhibitors and memantine allowed)
  • Caregiver able to attend all visits with patient

Who cannot join

  • Significant neurological disease other than AD
  • Major psychiatric illness
  • Significant systemic illness
  • Autoimmune disease
  • Prior treatment with experimental immunotherapeutics for AD including IVIG
  • Women of childbearing potential without birth control
  • Contraindication for MRI scan

Trial locations and contacts

31 sites in 6 countries.

31 sites in 6 countries

Germany8 sites

  • Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie

    Berlin, 14050

  • Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie

    Hamburg, 20251

  • Arzneimittelforschung Leipzig GmbH, Studienzentrum

    Leipzig, 04107

  • Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie

    Mannheim, 68159

  • Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München

    Munich, 81675

  • Studienzentrum PD Dr. Steinwachs

    Nuremberg, 90402

  • Klinikum Nürnberg Nord, Klinik f. Psychiatrie u. Psychotherapie

    Nuremberg, 90419

  • NeuroPoint GmbH

    Ulm/Donau, 89073

Other trials in Germany

Austria7 sites

  • Landeskrankenhaus Hall Gedächtnisambulanz

    Hall in Tirol, 6060

  • LNK Wagner-Jauregg, Dept. of geriatrics

    Linz, 4020

  • Christian Doppler Klinik, Univ. Klinik f. Neurologie

    Salzburg, 5020

  • Studienzentrum der PROSENEX, Ambulatoriumbetriebsges.m.b.H an der Confraternität - Privatklinik Josefstadt

    Vienna, 1080

  • MUW Klin. Pharmakologie und Klinik für Neurologie

    Vienna, 1090

  • MUW, Klin.Abt.f. Biolog. Psychiatrie

    Vienna, 1090

  • SMZ-Ost, Psychiatric Dep.

    Vienna, 1220

Other trials in Austria

France7 sites

  • CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard

    Bordeaux, 33076

  • Hôpital Neurologique Pierre Wertheimer

    Bron, 69500

  • Centre Hospitalier Universitaire (CHU) de Dijon

    Dijon, 21033

  • Centre Mémoire de Ressources et de Recherche, Service de Neurologie

    Montpellier, 34295

  • Hôpital de la Pitié-Salpêtrière

    Paris, 75651

  • CHU de rennes Site Hôtel Dieu

    Rennes, 35064

  • Hopital La Grave

    Toulouse, 31059

Other trials in France

Croatia5 sites

  • Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju

    Rijeka, 51000

  • Opća bolnica Varaždin, Klinika za Neurologiju

    Varaždin, 42000

  • "BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju

    Zagreb, 10000

  • Klinčki Bolnički Centar Zagreb (REBRO), Klinika za Neurologiju

    Zagreb, 10000

  • Psihijatrijska Bolnica Vrapče

    Zagreb, 10090

Other trials in Croatia

Czechia2 sites

  • University Thomayer Hospital

    Prague, 149 50

  • University Hospital Motol, Clinic of Neurology

    Prague, 150 06

Other trials in Czechia

Slovakia2 sites

  • EPAMED, s.r.o.

    Košice, 040 17

  • Psychiatric Hospital Michalovce

    Michalovce, 071 01

Other trials in Slovakia

About this study

Official title: A Randomized, Controlled, Parallel Group, Double-blind, Multi-center, Phase II Study to Assess the Clinical- and Immunological Activity,as Well as the Safety and Tolerability of Different Doses/Formulations of AFFITOPE AD02 Administered Repeatedly to Patients With Early Alzheimer's Disease

This is a multiple vaccination study to find out if it is a safe treatment and what effects it has on the symptoms of early Alzheimer's disease in male and female patients aged 50 to 80 years. Approximately 40 study sites in Europe will be involved. Patients will be randomized to receive either AFFITOPE AD02 or placebo. Each patient's participation will last 1 year.

Read the detailed description

AFFITOPE AD02 is a second generation AD immunotherapeutics targeting Aβ. Its active component is a synthetic peptide functionally mimicking the unmodified N-terminus of Aβ.

Being tested
active: AFFITOPE AD02, control: 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.

  • active: AFFITOPE AD02Biological

    Also called AFFITOPE AD02

    vaccination

  • control: PlaceboBiological

    Also called placebo, control

    vaccination

Study groups in NCT01117818
Study groupRoleWhat they receive
A: AFFITOPE AD02Active comparatorNot described
Receives: Biological: active: AFFITOPE AD02
B: AFFITOPE AD02Active comparatorNot described
Receives: Biological: active: AFFITOPE AD02
C: AFFITOPE AD02Active comparatorNot described
Receives: Biological: active: AFFITOPE AD02
D: Placebo controlActive comparatorNot described
Receives: Biological: control: Placebo

What is being measured

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

  1. cognitive(ADAS-cog modified) and functional(ADCS-ADL modified)

    Measured: 18 months

Secondary outcomes (1)

  1. cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI)

    Measured: 18 months

Timeline

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

  1. First posted6 May 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionDec 2013
  4. Study completionDec 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
335 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01117818
Sponsor's protocol ID
AFF006
Other IDs
2009-016504-22, 2009
Status last verified
Dec 2013
First submitted
19 Apr 2010
Last updated
11 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Haaland B, Dickson SP, Santana AF, Tanzi RE, Dubois B, Peters O, Grimmer T, Christensen J, Mallinckrodt C, Schneeberger A, Hendrix SB. Efficacy of AD04, an aluminum-based vaccine adjuvant, in patients with early Alzheimer's disease: Post hoc analysis of AFF006 (NCT01117818), a proof-of-concept, phase 2 randomized controlled trial. J Alzheimers Dis. 2025 Nov;108(1):234-242. doi: 10.1177/13872877251375985. Epub 2025 Sep 15.

    PubMed 40953123

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing active: AFFITOPE AD02 in people with Alzheimer's Disease, run by Affiris AG at 31 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 7 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 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Germany, Austria, France, Croatia, Czechia 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?

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?

cognitive(ADAS-cog modified) and functional(ADCS-ADL modified) (time frame: 18 months). 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 NCT01117818, 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 11 Dec 2013.

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