Study of Octagam 10% on the Treatment of Mild to Moderate Alzheimer's Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT00812565
First received: November 10, 2008
Last updated: May 6, 2013
Last verified: May 2013

November 10, 2008
May 6, 2013
December 2008
January 2011   (final data collection date for primary outcome measure)
To measure the change in amyloid beta peptide concentration of the blood plasma from immediately prior to the last IVIG infusion calculated over 2 or 4 weeks. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00812565 on ClinicalTrials.gov Archive Site
To measure changes from baseline in MRI, PET scan, neuropsychometric testing results, autoantibody concentrations in the blood and in CSF, CSF tau and pTau concentrations. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Octagam 10% on the Treatment of Mild to Moderate Alzheimer's Patients
Prospective 24-week, Double-blind, Randomized, Multicenter, Placebo-controlled Study Evaluating Safety and Change in Surrogate Parameters After Treatment With Increasing Dosages of Intravenous Immunoglobulin (IGIV) in Mild to Moderate Alzheimer's Disease

To evaluate the effect of 6 or 12 infusions of differenct dosages of IVIG 10% at regular study visit intervals on the reduction of amyloid beta peptide antibody in the CSF and the increase in the blood plasma in patients with mild to moderate Alzheimer's disease.

To evaluate the effect of 12 infusions of 0.1 g/kg, 0.25 g/kg or 0.4 g/kg IGIV 10% at a 2-week +/- 3 days interval or 6 infusions of 0.2 g/kg, 0.5 g/kg or 0.8 g/kg body weight IGIV 10% at a 4-week +/- 5 days interval on the reduction of +/- in the CSF and the increase in the blood plasma in mild to moderate AD patients.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
Biological: IVIG
Octagam 10%
Other Name: IVIG
  • Active Comparator: 1
    .1 g/kg IVIG @ 2 week infusion intervals
    Intervention: Biological: IVIG
  • Active Comparator: 2
    .25 g/kg IVIG @ 2 week infusion intervals
    Intervention: Biological: IVIG
  • Active Comparator: 3
    .4 g/kg IVIG @ 2 week intervals
    Intervention: Biological: IVIG
  • Active Comparator: 4
    .2 g/kg of IVIG infusions at 4 week intervals
    Intervention: Biological: IVIG
  • Active Comparator: 5
    .5 g/kg of IVIG infusions at 4 week intervals
    Intervention: Biological: IVIG
  • Active Comparator: 6
    .8 g/kg of IVIG infusions at 4 week intervals
    Intervention: Biological: IVIG
  • Placebo Comparator: 7
    Placebo infusion given at 4 week intervals
    Intervention: Biological: IVIG
  • Placebo Comparator: 8
    Placebo infusions given at 2 week intervals
    Intervention: Biological: IVIG
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 Mar;12(3):233-43. doi: 10.1016/S1474-4422(13)70014-0. Epub 2013 Jan 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Probable AD according to NINCDS-ADRDA criteria
  • Age: 50 to 85
  • MMSE: 16 to 26
  • Sufficient language skills for testing
  • Sufficient vision and hearing for testing
  • Modified Hachinski-Rosen Score < 5
  • MRI of the head consistent with the diagnosis of AD
  • Caregiver with contact at least 4 days per week for greater than 1 hour available
  • Outpatient status or assisted living
  • Post-menopause (women) as evidenced by lack of menstruation for at least 12 consecutive months or by having bilateral oophorectomy
  • Stable doses of approved AD medication(s) for at least 3 months prior to screening (e.g. AChE inhibitors, memantine)
  • Normal vital signs or clinically insignificant, if outside normal limits
  • Laboratory findings within normal limits or clinically insignificant, if outside normal limits
  • Normal ECG or clinically not significant, if outside normal limits

Exclusion Criteria:

  • Other causes of dementia (e.g. vascular dementia, Lewy-body dementia, fronto-temporal dementia, Creutzfeld-Jacob disease, Huntington's disease, Parkinson's disease)
  • History of or present significant other diseases of the central nervous system (e.g. brain tumor, normal pressure hydrocephalus, Parkinson's Disease, stroke, severe brain trauma, brain surgery, epilepsy, encephalitis)
  • Geriatric depression scale of > 7 (short form with scale from 0 to 15)
  • Present significant psychiatric disorder (e.g. major depression)
  • History of psychosis or hallucinations
  • Mental retardation
  • Unstable medical disease in the opinion of the investigator
  • Insulin dependent diabetes mellitus
  • Acute infectious disease
  • Vitamin B12 deficiency, though on stable replacement therapy for at least 3 months is acceptable
  • Unstable thyroid dysfunction
  • Uncontrolled hypertension
  • Severe liver or kidney disease
  • Major surgery within three months prior to screening
  • Prohibited medications: antiepileptic drugs, antipsychotics (but allowed for treatment of acute episodes), antiparkinson agents, anticholinergic drugs, selegiline, MAOI, tricyclics, immuno¬suppressive medications, anti-histamines (unless on a stable dose for at least 3 months or used for treatment of acute episodes), benzo¬diazepines (but allowed for treatment of acute episodes), and Lithium
  • Antidepressants are permitted, if on stable dose for at least 3 months and without significant anticholinergic side-effects
  • Peripheral venous conditions, which impair establishing regular venous access for infusions
  • Medical conditions, which interfere with protein catabolism (e.g. nephrotic syndrome)
  • Known blood hyperviscosity, or other hypercoagulable states
  • Deep vein thrombosis within preceding 4 years
  • Symptomatic stroke
  • Transient ischemic attack (TIA) within preceding 2 years
  • Participation in other drug trial within the previous 3 months before screening
  • Participation in immunological treatment studies of AD other than with IGIV within the previous 6 months before screening.
  • IGIV use in the previous six months
  • Live viral vaccination within the last month before study entry.
  • Not eligible for lumbar puncture (anticoagulant therapy, coagulation disorders, severe spinal alterations)
  • Patients with a past or present history of drug abuse or alcohol abuse within the preceding 5 years
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00812565
GAM10-04
Yes
Octapharma
Octapharma
Not Provided
Study Director: Wolfgang Frenzel, M.D. Octapharma Pharmazeutika Produktionsges.m.b.H., Vienna, Austria".
Octapharma
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP