Has your loved one been diagnosed with Alzheimer's Disease?

Study Rationale: Alzheimer’s disease is the most common form of dementia among the elderly, and is characterized by the loss of cells in the brain. Researchers suspect that the development of two abnormal structures, called plaques and tangles, to be responsible for destruction of nerve cells. Plaques are dense and consist of deposits of a protein called amyloid-beta peptide (Aβ). Studies have suggested that increased levels of auto-antibodies against Aβ reduce plaque formations and may reduce the progression of the disease. Preliminary data shows that a therapy called, Intravenous Immunoglobulin (IVIG), may increase auto-antibodies against Aβ and thus could be used to treat patients with mild to moderate Alzheimer’s disease. 

Study Objective:  To evaluate the effect of IVIG in mild to moderate Alzheimer’s disease by showing a reduction of Ab in the cerebral spinal fluid (CSF) and increase in the blood plasma. In addition, to find changes in patient’s psychiatric/cognitive performance and brain images (MRI and PET scans). 

Study Description: The study will last approximately 6 months. Patients will be randomly assigned to receive Octagamâ 10% or placebo through IV-infusions 12 times every 2 weeks or 6 times every 4 weeks. In addition to treatment visits, patients will undergo study screening procedures, baseline measurements, and follow-up visits.

Patient Profile: We are seeking patients who meet the general criteria below.  Additional criteria may apply      

Male and female patients between 50 and 85 years old (inclusive)

Diagnosed with probable Alzheimer’s Disease

-If taking  Alzheimer’s medication(s) (Namenda, Cognex, Aricept, Reminyl, Exelon etc.) the dose of medication must be stable for  at least 3 months    

-   No history of other neurological disorder(s) or brain trauma (Parkinson’s, Huntington’s, vascular dementia, stroke, epilepsy, major depressive disorder, etc.)

-   Sufficient language, hearing, and vision abilities 

- Out-patient status with a caregiver available to assist patient with study appointments      

-Able to complete study procedures (MRI, Petscan, lab samples, infusions, and cognitive testing)

 Costs: There is no cost to participate. Patients may be reimbursed for their time and travel as a result of study participation.   Information: contact Lauren Friedman at 303.773.9000 or Lfriedman@immunoe.com


Have you or a loved one been diagnosed with Multifocal Motor Neuropathy?

Description: Multifocal Motor Neuropathy (MMN) is a progressive muscle disorder characterized by muscle weakness in the arms or legs, with one side affected more than the other.  The disease is thought to have an immune component and is often treated with immune-modifying therapies.  This study is being done to examine the effectiveness of intravenous immunoglobulin (IVIG) for the treatment of MMN.

Qualifications Include:

- Over the age of 18

- Diagnosis of  definite or probable MMN

- Must be on a stable regime of IVIG for at least 3 months

The duration of this study is approximately 15 months.  Participants may be compensated for time and travel. 

For more information please call 303.773.9000, or email lfriedman@immunoe.com


Do you have relapsing remitting
multiple sclerosis?

Principal Investigator: Isaac Melamed

Location: Centennial, CO

Description: There is currently no therapy for Relapsing Remitting Multiple Sclerosis (RRMS) that is easy to administer and does not involve painful injections. Become part of a study to pursue an oral treatment for RRMS.

Qualifications Include: 
- Ages 18 to 55 years
- Have a confirmed diagnosis of RRMS
- Have had at least one relapse in the last 12 months or two relapses in the last 24 months 
- Ambulatory
- Have no other chronic medical conditions

The study involves 10-12 office visits over a 2 year period. Patients will receive at no cost: MRIs, Physical Exams, Neurological Exams, Investigational medicine, care from an experienced medical team, and up to $550 dollars compensation for time and travel.

For further information feel free to contact the study coordinator, Lauren Friedman, at 303-224-4700 or by email Lfriedman@1sthealthcenters.com

IMMUNOe International Research Centers
6801 S. Yosemite Street
Centennial, CO 80112
303.773.9000

Click here to volunteer for a research study. 


A brief introduction to the DELIVER study

Study Objective: The purpose of this investigational study is to look at two other ways of using natalizumab: subcutaneously (SC) injection (under the skin) and intramuscularly (IM) injection (into the muscle). A range of doses will be administered to better understand the safety of giving natalizumab these ways, as well as, how long natalizumab stays in the body and the effects it has on the body. SC and IM injections would reduce the amount of time required for treatment and eliminate the need for patients to go to an infusion center. This investigational study will help to determine if it may be possible to use these ways of natalizumab administration in the future.

Study Description: Neurologist, Dr. Ronald Murray, will oversee all study activities. The study will last approximately 1 year and 8 months and is sponsored by Biogen Idec, Inc. Patients are assigned to receive natalizumab through an intravenous (IV) infusion, subcutaneous injection, intramuscular injections, or a reference group.In the first two months, all patients will attend 1 screening visit (over a minimum of five days) and 1 office visit to determine treatment group assignments (baseline visit). Patients assigned to one of the five natalizumab groups will receive an initial dose of medication at the baseline visit and will return for blood draw visits throughout 8 weeks (4 in 1st week and 7 in the following 7 weeks). At the beginning of the third month, patients will return once a month for their assigned dosing. Patients in the reference group will receive standard treatment of care (e.g. Copaxone®, Rebif®, Avonex®) and will begin monthly natalizumab dosing at month 8.

Study Rationale: While other Multiple Sclerosis medications can be administered at home, natalizumab is given through IV at infusion centers. This can be costly and inconvenient to patients, especially if there is not an infusion center near by. In addition, as there is a lack of approved treatments for Secondary Progressive Multiple Sclerosis (“SPMS”), one of the purposes of this study is to find out if natalizumab is safe and well-tolerated in patients with SPMS when it is administered for several months.

Qualifications Include: 
- Male and Females between 18 to 65
- Diagnosed with secondary Progressive MS (No RRMS or PPMS patients)
- Must be natalizumab naïve
- EDSS between 2.5 and 6.5 (wheel chair bound = 7 and these patients are excluded)
- No other conflicting medical condition which would jeopardize the patient or study data
- Able to undergo an MRI (lasting an hour)

Compensation: Natalizumab will be supplied by Biogen Idec while you participate in this study. You will be reimbursed for any reasonable travel costs incurred as a result of your participation in this study.

For further information contact the study coordinator, Lauren Friedman, at 303.773.9000 or by email Lfriedman@immunoe.com

IMMUNOe Health Centers
6801 S. Yosemite Street
Centennial, CO 80112
303.773.9000
 

Click here to volunteer for a research study. 




Do you have relapsing MS?

Study Objective: Tysabri is a monoclonal antibody that has been approved for the treatment of relapsing forms of MS. Tysabri is designed to hamper the movement of potentially damaging immune cells from the bloodstream, across the “blood-brain barrier,” and into the brain and spinal cord. The drug inhibits this movement by attaching to alpha 4-integrin, a protein on the surface of immune T-cells that normally enables them to adhere to and then pass through the blood-brain barrier.

Vaccines are an important part of healthy living with MS; most are safe for people with this disease. No information is available on how Tysabri affects the immune response that occurs when people receive vaccinations. This study is designed to provide this information.

Study Description: The study is being conducted at several sites across the United States, including Dr. Ronald Murray in the south Denver Metro area. Patients are assigned to receive either TYSABRI® in conjugation with two vaccinations over an 8 month period or two vaccinations alone (without treatment) over a 2 month period. The two vaccines include, the Tetanus Diphtheria Vaccine (common in the general population, this vaccine will be used to assess recall response) and IMMUCOTHEL also called keyhole limpet hemocyanin (uncommon in the general population, this vaccine will be used to assess the primary humoral response).

Qualifications Include: 
- Be between 18 and 60 years old
- Have a documented diagnosis of a relapsing forms of MS
- Have a known history of tetanus vaccination
- Be willing to discontinue and remain free from other MS therapies
- Have never been treated with TYSABRI® in the past
- Do not have a history of cancer
- Have no known history to shellfish or any severe allergic or anaphylactic reactions
- Willing to attend a maximum of 11 office visits over 8 months
- Are qualified to participate in the opinion of the Investigator (Dr. Murray)

Compensation: Participants will receive study drug as well as study related health care from an experienced medical team at no cost. Compensation for time and travel will also be given.

For further information contact the study coordinator, Lauren Friedman, at 303.773.9000 or by email Lfriedman@immunoe.com

IMMUNOe Health Centers
6801 S. Yosemite Street
Centennial, CO 80112
303.773.9000

Click here to volunteer for a research study. 

 
 
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