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 Alzheimers type under treatment with increasing dosages of intravenous immunoglobulin (Octagam® 10%)
ISRCTN | ISRCTN64846759 |
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DOI | https://doi.org/10.1186/ISRCTN64846759 |
ClinicalTrials.gov number | NCT00812565 |
Secondary identifying numbers | GAM10-04 |
- Submission date
- 23/01/2009
- Registration date
- 28/01/2009
- Last edited
- 22/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Stefan Wietek
Scientific
Scientific
Oberlaaer Str. 235
Vienna
1100
Austria
Phone | +43 (0)1 61032 1778 |
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stefan.wietek@octapharma.com |
Study information
Study design | Prospective multicentre double-blind randomised placebo-controlled phase II study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
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 Alzheimers type under treatment with increasing dosages of intravenous immunoglobulin (Octagam® 10%) |
Study objectives | Comparison of different dosages and intervals of intravenous immunoglobulin (IVIG) treatment on surrogate parameters for Alzheimer's disease progression. |
Ethics approval(s) | 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 |
Health condition(s) or problem(s) studied | Alzheimer's disease (mild to moderate) |
Intervention | 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 | Drug |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | Octagam® |
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 study start date | 01/02/2009 |
Completion date | 21/09/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Both |
Target number of participants | 56 (7 patients per arm) |
Key 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 |
Key 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 |
Date of first enrolment | 01/02/2009 |
Date of final enrolment | 21/09/2010 |
Locations
Countries of recruitment
- Austria
- Germany
- United States of America
Study participating centre
Oberlaaer Str. 235
Vienna
1100
Austria
1100
Austria
Sponsor information
Octapharma AG (Switzerland)
Industry
Industry
Seidenstrasse 2
Lachen
CH-8853
Switzerland
Website | http://www.octapharma.com |
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https://ror.org/002k5fe57 |
Funders
Funder type
Industry
Octapharma AG (Switzerland)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Basic results | No | No | |||
Results article | results | 01/03/2013 | Yes | No |
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.