Study of Octagam 10% on the Treatment of Mild to Moderate Alzheimer's Patients - Full Text View

Sponsored by:	Octapharma
Information provided by:	Octapharma
ClinicalTrials.gov Identifier:	NCT00812565

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease	Biological: IVIG	Phase II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	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

Further study details as provided by Octapharma:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	56
Study Start Date:	December 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator .1 g/kg IVIG @ 2 week infusion intervals	Biological: IVIG Octagam 10%
2: Active Comparator .25 g/kg IVIG @ 2 week infusion intervals	Biological: IVIG Octagam 10%
3: Active Comparator .4 g/kg IVIG @ 2 week intervals	Biological: IVIG Octagam 10%
4: Active Comparator .2 g/kg of IVIG infusions at 4 week intervals	Biological: IVIG Octagam 10%
5: Active Comparator .5 g/kg of IVIG infusions at 4 week intervals	Biological: IVIG Octagam 10%
6: Active Comparator .8 g/kg of IVIG infusions at 4 week intervals	Biological: IVIG Octagam 10%
7: Placebo Comparator Placebo infusion given at 4 week intervals	Biological: IVIG Octagam 10%
8: Placebo Comparator Placebo infusions given at 2 week intervals	Biological: IVIG Octagam 10%

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812565

Contacts

Contact: Michael Eppolito, M.B.A.	949-360-0669	michael.eppolito@octapharma.com
Contact: Toze Reichard	201-604-1125	toze.reichard@octapharma.com

Locations

United States, New Jersey
Octapharma USA	Recruiting
Hoboken, New Jersey, United States
Principal Investigator: Martin Farlow, M.D.
Principal Investigator: James Stevens, M.D.
Principal Investigator: Ralph Richter, M.D.

Sponsors and Collaborators

Octapharma

Investigators

Study Director:

Wolfgang Frenzel, M.D.

Octapharma AG

More Information

Responsible Party:	Octapharma AG ( Robin Scully, R.N., M.B.A. )
Study ID Numbers:	GAM10-04
Study First Received:	November 10, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00812565
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Alzheimer Disease
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Cognition Disorders
Antibodies
Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Dementia
Delirium
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Nervous System Diseases
Tauopathies
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009