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

Information source: Octapharma
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease

Intervention: IVIG (Biological)

Phase: Phase 2

Status: Recruiting

Sponsored by: Octapharma

Official(s) and/or principal investigator(s):
Wolfgang Frenzel, M.D., Study Director, Affiliation: Octapharma AG

Overall contact:
Michael Eppolito, M.B.A., Phone: 949-360-0669, Email: michael.eppolito@octapharma.com

Summary

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.

Clinical Details

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Primary outcome: 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.

Secondary outcome: 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.

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

Minimum age: 50 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

Michael Eppolito, M.B.A., Phone: 949-360-0669, Email: michael.eppolito@octapharma.com

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

Starting date: December 2008
Ending date: September 2009
Last updated: December 19, 2008

Page last updated: October 19, 2009

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