A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild to Moderate Alzheimer´s Disease

Condition: Alzheimer´s Disease

What is the purpose of this trial?

The purpose of this study is to determine whether IGIV, 10% treatment, administered at two different doses for 9 and 18 months, results in a significantly slower rate of decline of dementia symptoms in subjects with mild to moderate Alzheimer´s Disease (AD). Subjects will be randomly assigned to receive intravenous infusions of either of two doses of IGIV, 10% or placebo every two weeks for 70 weeks (36 infusions) as an add-on to conventional Food and Drug Administration (FDA)-approved AD medications.

Start Date: December 2008
Study Status: Recruiting

Who can participate?

Ages Eligible: 50 Years - 89 Years
Gender Eligible: Both

Inclusion Criteria:

- Written informed consent - subject (or subject6s legally acceptable representative)
and caregiver who are willing and able to participate for the duration of the study

- Diagnosis of probable Alzheimer6s Disease (AD)

- Dementia of mild to moderate severity defined as mini-mental state examination (MMSE)
16-26 inclusive at the time of screening

- Neuroimaging (computed tomography [CT] or MRI) performed after symptom onset
consistent with AD diagnosis

- Ability to comply with testing and infusion regimen, including fluency in English or
Spanish, adequate corrected visual acuity and hearing ability

- On stable doses of FDA approved AD medication(s) for at least 3 months prior to
screening. These medications must be continued throughout this study.

- If receiving psychoactive medications (e.g. antidepressants other than monoamine
oxidase inhibitors (MAOIs) and most tricyclics, antipsychotics, anxiolytics,
anticonvulsants, mood stabilizers, etc), must be on stable doses for at least 6 weeks
prior to screening

Exclusion Criteria (Reasons why it might not be appropriate to participate):

- Any other forms of dementia

- Medical issues that might increase the risk of treatment with IGIV, 10%, such as:

1. Significant problems with blood pressure, heart disease, clotting disorders,
strokes or recent heart attacks

2. Evidence of current bleeding in the brain by MRI

3. Serious problems with the liver or kidneys

4. Allergies to blood products

- Medical issues that might interfere with the evaluation of the treatment of dementia
or might make dementia worse, such as:

1. Diabetes

2. Recent treatment with chemotherapy or immune suppression

3. The recent use of other investigational drugs, especially antibody therapy for
AD

4. Severe headaches or psychiatric problems

There are other reasons why it might not be appropriate to pariticipate in this trial.
Please consult an investigator at one of the trial sites for details.

Sponsors: Baxter Healthcare Corporation, Alzheimer's Disease Cooperative Study (ADCS)
Phase: Phase 3

First Received: January 7, 2009
Last Updated: March 4, 2010
Clinicaltrials.gov ID: NCT00818662
Study HIC # 0811004451

Condition: Alzheimer´s Disease

Interventions: Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%);
Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%);
Other: Placebo solution

What is the purpose of this trial?

show additional information...

Date: December 2008
Study Status: Recruiting

Who can participate?

Ages Eligible: 50 Years - 89 Years
Gender Eligible: Both

Inclusion Criteria:

- Written informed consent - subject (or subject´s legally acceptable representative)
and caregiver who are willing and able to participate for the duration of the study

- Diagnosis of probable Alzheimer´s Disease (AD)

- Dementia of mild to moderate severity defined as mini-mental state examination (MMSE)
16-26 inclusive at the time of screening

- Neuroimaging (computed tomography [CT] or MRI) performed after symptom onset
consistent with AD diagnosis

- Ability to comply with testing and infusion regimen, including fluency in English or
Spanish, adequate corrected visual acuity and hearing ability

- On stable doses of FDA approved AD medication(s) for at least 3 months prior to
screening. These medications must be continued throughout this study.

- If receiving psychoactive medications (e.g. antidepressants other than monoamine
oxidase inhibitors (MAOIs) and most tricyclics, antipsychotics, anxiolytics,
anticonvulsants, mood stabilizers, etc), must be on stable doses for at least 6 weeks
prior to screening

Exclusion Criteria (Reasons why it might not be appropriate to participate):

- Any other forms of dementia

- Medical issues that might increase the risk of treatment with IGIV, 10%, such as:

1. Significant problems with blood pressure, heart disease, clotting disorders,
strokes or recent heart attacks

2. Evidence of current bleeding in the brain by MRI

3. Serious problems with the liver or kidneys

4. Allergies to blood products

- Medical issues that might interfere with the evaluation of the treatment of dementia
or might make dementia worse, such as:

1. Diabetes

2. Recent treatment with chemotherapy or immune suppression

3. The recent use of other investigational drugs, especially antibody therapy for
AD

4. Severe headaches or psychiatric problems

There are other reasons why it might not be appropriate to pariticipate in this trial.
Please consult an investigator at one of the trial sites for details.