A Phase IIA, Multi-Center, Randomized, Third-Party UnBlinded, Adjuvant-Controlled, Multiple-Ascending Dose Safety, Tolerability and Immunogenicity Trial of ACC-001 with QS-21 Adjuvant in Patients with Mild to Moderate Alzheimer's Disease

Study Status: 
Closed
Study Description: 

We are seeking Alzheimer's disease patients to evaluate the safety of a new investigational drug called ACC-001 that may be a possible treatment for Alzheimer's disease. ACC-001 is an investigational drug not currently-approved by the US Food and Drug Administration (FDA).

 

Subjects will be randomly-assigned to receive drug or placebo (contains no active medication).  Subjects must have a study partner or caregiver who is able to come to twenty-four clinic visits over the course of two years. Study participants will be reimbursed for parking.  All information is kept completely confidential.

 

ELIGIBILITY CRITERIA

 

Inclusion criteria:

1. Fifty to eighty-five years of age.

2. Diagnosis of mild to moderate Alzheimer's disease (MMSE 16-26).

3. Have been on stable doses of FDA-approved treatments such as Aricept, Reminyl, Exelon, and/or Namenda (Memantine) for at least sixty days.

 

Exclusion criteria:

1. Significant neurological disease other than Alzheimer's disease.

2. Clinically-significant and/or un-controlled medical condition.

3. USe of an investigational drug within thirty days prior to the screening visit or during the entire study.

4. Previous treatment with immuno-therapy for Alzheimer's disease.

Study Coordinator(s): 

Martha Vander Vleit, RN

Tel:  617-732-8085