Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Stefan Wietek


Contact details

Oberlaaer Str. 235
+43 (0)1 61032 1778

Additional identifiers

EudraCT number number


Protocol/serial number


Study information

Scientific title

Prospective 24-week, double-blind, randomised, placebo-controlled, multicentre study evaluating safety and change in efficacy-related surrogate parameters in patients with dementia of the Alzheimer’s type under treatment with increasing dosages of intravenous immunoglobulin (Octagam® 10%)


Study hypothesis

Comparison of different dosages and intervals of intravenous immunoglobulin (IVIG) treatment on surrogate parameters for Alzheimer's disease progression.

Ethics approval

1. Central Ethics Committee EC Marburg (Germany)
2. Local Institutional Review Boards (IRBs) of three Unites States of America (USA) sites; approval of protocol amendment no. 2 by IUPUI/Clarian IRB (Indianapolis, USA), 08/01/2009, ref: 0811-07

Study design

Prospective multicentre double-blind randomised placebo-controlled phase II study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Alzheimer's disease (mild to moderate)


Octagam 10% (12 infusions of 0.1 g/kg, 0.25 g/kg or 0.4 g/kg every 2 weeks or 6 infusions of 0.2 g/kg, 0.5 g/kg or 0.8 g/kg every 4 weeks) or matching placebo.

Blood samples will be drawn before each infusion and at day 1, 4, 7, 14, 21 and 28 (the latter two only for patients on 4-week interval) after last infusion. Lumbar puncture will be performed at baseline and 1 day after last infusion, MRI at screening, week 12 and 24 and 18-fluoro-2-deoxy-glucose-positron emission tomography (FDG-PET) scans at baseline and week 24.

Intervention type



Phase II

Drug names


Primary outcome measure

Evaluation of the decrease of total amyloid beta in the central nervous system (CNS) and the increase in blood plasma after 24 weeks (area under curve [AUC] of total amyloid beta [Abeta] concentration in plasma).

Secondary outcome measures

1. Further characterisation of the decrease of amyloid beta in the cerebrospinal fluid (CSF) and the increase in blood plasma by measuring an additional surrogate parameter (biomarker, Ab1-42), by assessing the changes in the biomarker proteins Tau and phosphorylated Tau (pTau 181) after 6 months of treatment and of the anti-Ab autoantibodies during the 6-month treatment period
2. Change in Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog), MMSE, Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) and Clinical Dementia Rating Sum of Boxes (CDR-SOB) at week 12 and 24 compared to baseline
3. Change in whole brain and hippocampal volume on volumetric MRI at week 12 and 24 compared to screening
4. Change in cerebral glucose metabolism determined by FDG-PET at week 24 compared to baseline

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Probable Alzheimer's disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
2. Written informed consent by patient or, for significantly cognitively impaired individuals, their legally authorised representative
3. Aged greater than or equal to 50 and less than or equal to 85 years, either sex
4. Mini-mental State Examination (MMSE) greater than or equal to 16 and less than or equal to 26
5. Only for Germany: the patient's capacity to consent has to be confirmed by dated signature on the informed consent form by a second independent investigator who is otherwise not involved in study GAM10-04
6. Modified Hachinski-Rosen Score less than 5
7. Magnetic resonance imaging (MRI) of the head consistent with the diagnosis of AD

Participant type


Age group




Target number of participants

56 (7 patients per arm)

Participant exclusion criteria

1. Other causes of dementia (e.g. vascular dementia, Lewy Body dementia, fronto-temporal dementia, Creutzfeld-Jacob disease, Huntington's disease, Parkinson's disease)
2. History of or present significant other diseases of the central nervous system (e.g. brain tumour, normal pressure hydrocephalus, stroke, severe brain trauma, brain surgery, epilepsy, encephalitis)
3. Geriatric depression scale of greater than 7 (short form with scale from 0 to 15)
4. Present significant psychiatric disorder (e.g. major depression)
5. History of psychosis or hallucinations
6. Mental retardation
7. Unstable medical disease in the opinion of the investigator
8. Insulin dependent diabetes mellitus
9. Acute infectious disease
10. Uncontrolled hypertension (diastolic blood pressure [BP] greater than 90 mmHg or systolic BP greater than 160 mmHg; sitting)
11. Symptomatic stroke
12. Transient ischaemic attack (TIA) within preceding 2 years
13. Participation in other drug trial currently or within the previous 3 months before screening

Recruitment start date


Recruitment end date



Countries of recruitment

Germany, United States of America

Trial participating centre

Oberlaaer Str. 235

Sponsor information


Octapharma AG (Switzerland)

Sponsor details

Seidenstrasse 2

Sponsor type




Funder type


Funder name

Octapharma AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)


Publication list

2013 results in

Publication citations

  1. Results

    Dodel R, Rominger A, Bartenstein P, Barkhof F, Blennow K, Förster S, Winter Y, Bach JP, Popp J, Alferink J, Wiltfang J, Buerger K, Otto M, Antuono P, Jacoby M, Richter R, Stevens J, Melamed I, Goldstein J, Haag S, Wietek S, Farlow M, Jessen F, Intravenous immunoglobulin for treatment of mild-to-moderate Alzheimer's disease: a phase 2, randomised, double-blind, placebo-controlled, dose-finding trial., Lancet Neurol, 2013, 12, 3, 233-243, doi: 10.1016/S1474-4422(13)70014-0.

Additional files

Editorial Notes

22/03/2016: added link to results - basic reporting. On 10/04/2013 the overall trial end date was changed from 01/11/2009 to 21/09/2010.