Trial Information

Summary: Does someone you know suffer from Vascular Dementia? They may qualify for a research study evaluating an investigational drug being tested for improved mental function.

About this Clinical Trial

In recent clinical trials involving more than 4,000 participants, an investigational drug was shown to improve cognition and function in some patients with Alzheimer’s Disease.

Because the devastating cognitive and functional deterioration that characterize Alzheimer’s Disease and Vascular Dementia are similar, researchers want to determine if the study drug may potentially help some Vascular Dementia patients in similar ways.

This research study will evaluate whether the study drug can safely and effectively treat Vascular Dementia and measure its effects on activities of daily living, behavior, and mental functioning. Because there is no approved treatment for the disorder at present, this clinical trial may prove useful in guiding the development of new therapies designed to improve the quality of life for Vascular Dementia patients and persons with similar conditions.

Eligibility Requirements

Both men and women may participate in this clinical trial. To be considered for inclusion, participants must meet each of the following specific requirements:

• Have a diagnosis of Vascular Dementia in the mild to moderate range with the verified presence of Cerebrovascular Disease confirmed by a MRI or CT scan within the past 12 months. If Alzheimer’s Disease has previously been diagnosed, they may not be eligible for this trial
• Disease onset between ages 40-90 years old
• Must be able to participate in neuropsychological testing; precluding impairments such as disturbances of consciousness and delirium
• Opportunity to independently perform specific activities of daily living
• Daily or frequent (at least five days per week) visits by a relative, friend, or paid caregiver who is prepared to assist with the study medication, attend assessments with the subject, and provide assistance throughout the trial
• Ability to read, write, and fully understand the language of cognitive tests used during the study; the ability to see, hear (glasses and hearing aids are permitted), and speak, and willingness to complete serial cognitive tests
• Informed consent from the subject or his/her legally accepted representative and the caregiver

There are also exclusion criteria in this clinical trial, and individuals who meet any of them may not participate in this investigation:

• Degenerative neurological disorders such as: Parkinson’s Disease, Pick’s Disease or Huntington’s Chorea, Down’s Syndrome, or Creutzfeldt-Jacob Disease; mild disorders for which no treatment is required does not exclude subjects Mental retardation or cognitive impairment caused by: acute injury to the brain, oxygen deprivation, vitamin deficiency, stroke, brain cancer, severe infection, thyroid or similar diseases, or severe kidney failure
• Co-existing medical conditions such as: uncontrolled seizures, schizophrenia, severe depression, moderate to severe behavioral disturbance (individuals with mild disturbance that is well-controlled with medication may be included), peptic ulcer, clinically significant liver, kidney, lung, and metabolic disorders, or clinically significant urinary outflow obstruction
• Cardiac surgery within the past 6 months or cardiovascular disease that could limit a participant’s ability to complete a 26-week study including: myocardial infarction or unstable disease; congestive heart failure (some CHF patients with minimal symptoms may be included); abnormal heart rhythms altering mental status (some atrial fibrillation patients may be included); severe heart valve disease; or uncontrolled high or low blood pressure
• FDA-approved, experimental, or OTC medications (including nutritional supplements) used to treat dementia must be discontinued after enrollment in the trial
• Women of childbearing potential without adequate contraception or who are pregnant at the time of screening or who do not agree to avoid becoming pregnant during the study
• History of severe drug allergy or hypersensitivity or conditions that could interfere with study drug absorption or with disease evaluation; previous enrollment in investigational trials; drug or alcohol abuse within the last year or a lengthy prior history of involvement

If accepted, participants will visit a study doctor as outpatients and will receive either the trial drug or placebo (1 out of 2 patients receive active study drug). Physical examinations and psychological testing will be performed and blood for laboratory studies will be collected. Participants should expect eight doctor visits - two to three hours each - over eight months at the study physician’s offices.

Every participant will receive study related monitoring by a physician and laboratory services without cost throughout the entire trial:

• Participants receive study related psychiatric and neurological care for six months while participating in the study.
• Participants will receive study medications.
• Participants will receive study related MRI or CT scan to confirm diagnosis if one has not been done in the past 12 months.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.