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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%)
DOI 10.1186/ISRCTN64846759
ClinicalTrials.gov identifier NCT00812565
EudraCT number
Public 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%)
Scientific title
Acronym N/A
Serial number at source GAM10-04
Study hypothesis Comparison of different dosages and intervals of intravenous immunoglobulin (IVIG) treatment on surrogate parameters for Alzheimer's disease progression.

Please note that as of 10/04/2013, the anticipated end date for this study was updated from 01/11/2009 to 21/09/2010
Lay summary Not provided at time of registration
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) on 8th January 2009 (ref: 0811-07)
Study design Prospective multicentre double-blind randomised placebo-controlled phase II study
Countries of recruitment Germany, United States of America
Disease/condition/study domain Alzheimer's disease (mild to moderate)
Participants - 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
Participants - 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
Anticipated start date 01/02/2009
Anticipated end date 21/09/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 56 (7 patients per arm)
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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
Sources of funding Octapharma AG (Switzerland)
Trial website
Publications 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23375965
Contact name Dr  Stefan  Wietek
  Address Oberlaaer Str. 235
  City/town Vienna
  Zip/Postcode 1100
  Country Austria
  Tel +43 (0)1 61032 1778
  Fax +43 (0)1 61032 9249
  Email stefan.wietek@octapharma.com
Sponsor Octapharma AG (Switzerland)
  Address Seidenstrasse 2
  City/town Lachen
  Zip/Postcode CH-8853
  Country Switzerland
  Sponsor website: http://www.octapharma.com
Date applied 23/01/2009
Last edited 07/05/2013
Date ISRCTN assigned 28/01/2009
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