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ALZHEIMER'S DISEASE RESEARCH CENTERS OF CALIFORNIA (ARCC) PROJECTS

The following is a list of current ARCC projects with inclusion criteria. Please contact Margaret Villa [(323) 442-7600 or mvilla@usc.edu] or Liberty Teodoro [(323) 442-7600 or lteodoro@usc.edu] for more information.

Project 1: Procedural Memory in Alzheimer's Disease
»To learn more about the study, please click here

Project 2: Cognitive, Behavioral, and Functional Differences between Frontal Variant Alzheimer's Disease and Conventional Alzheimer's
»To learn more about the study, please click here

Project 3: Alzheimer's Disease Treatment Evaluation Study
»To learn more about the study, please click here

Project 4: Depression in Alzheimer's Disease Study (DAD)
»To learn more about the study, please click here

Project 5: Frontotemporal Dementia Consortium
»To learn more about the study, please click here


Project 1: Procedural Memory in Alzheimer's Disease

We are performing a study to examine the procedural memory of individuals with Alzheimer’s Disease. Procedural memory involves the memory for procedures such as everyday tasks. This kind of memory is best studied by measuring performance on movement tasks. The study of procedural memory in Alzheimer’s disease is important as it may lead to therapeutic techniques designed to lessen the burden of care placed on families and caregivers.

Completion of this study will take approximately one (1) hour. Subjects will be asked to do three (3) different tasks. First, they will move a pen back and forth between two targets as fast as they can for 10 seconds trials. Next, they will push some keys on a computer keyboard in response to the illumination of a lighted circle on the screen. Last, their ability to perform several simple activities of daily life (ADL) will be assessed (such as putting a letter in an envelope, drinking from a glass, and buttoning a shirt. These ADL tasks will be timed.

Inclusion Criteria:

A Mini-Mental Score of greater than 10 are appropriate for this study. Additionally, they should be able to move both arms without pain and be free from concomitant psychological symptoms (e.g. irritability, argumentativeness, combativeness).



Project 2: Cognitive, Behavioral, and Functional Differences Between Frontal Variant Alzheimer's Disease and conventional Alzheimer's

We are conducting a study to determine whether a particular subtype of Alzheimer’s disease (e.g., Frontal Variant AD) is associated with increased functional disability, more neuropsychiatric symptoms, and greater caregiver distress, relative to conventional or typical Alzheimer’s disease patients. The study will have important implications in that it will 1) provide additional support for the existence of a frontal variant Alzheimer’s disease subtype, and 2) help identify patients and caregivers in need of targeted treatment.

Inclusion Criteria:

  • Diagnosis of Alzheimer’s disease
  • Mini-Mental State Examination score ≥ 20
  • Fluent in English
  • Caregiver available
The evaluation consists of the administration of a battery of neuropsychological measures to the patient, and several brief measures will be given to the caregiver regarding their caregiving experience and the patient’s behavioral symptoms. The length of the evaluation is approximately 2 to 3 hours.



Project 3: Alzheimer's Disease Treatment Evaluation Study

To evaluate the long-term effectiveness of Alzheimer’s disease (AD) patient treatments in ordinary California clinical practice. AD patients who receive anti-Alzheimer’s medications from their clinicians will be compared to AD patients who do not receive such medications. The specific goal is to identify predictors of positive AD treatment that would be readily available to clinicians in all health care settings.

Inclusion Criteria:

Must be women and men aged 55 to 90 of any racial or ethnic group, with a diagnosis of possible or probable Alzheimer’s Disease (AD) by NINCDS-ADRDA criteria. Patients may have CNS disorders or other diagnoses in addition to AD, e.g. May be “Mixed Dementia” such as AD + Vascular dementia. Patients should live with someone, or be visited regularly by a caregiver or monitor.

A MMSE minimum score of 5 is required, and patients must not be bottomed out on all measures i.e. must be capable of showing deterioration on some measures. Subjects should be selected from the population of AD patients who are sometimes treated with anti-AD drugs e.g. avoid patients who are terminally bed-ridden. All subjects must be free for six weeks of FDA-approved anti-Alzheimer’s Disease medications at their baseline assessment. After the initial medication-free assessment, both patients who are prescribed donepezil or other FDA-approved anti-Alzheimer’s Disease medications and those who are not, may be enrolled. Patient must have willingness to participate in the study, and sign the consent form (or have a caregiver sign).

Exclusion:

Patients cannot enroll in this Treatment Evaluation if they are currently enrolled in a Phase 1, 2, 3 investigational drug study or in another randomized clinical trial of an unproved treatment. Patients who participate in clinical trials following their enrollment in this Treatment Evaluation study will continue to be followed. Patients who have participated in other anti-Alzheimer’s Disease drug trials may enroll in this AD Treatment Evaluation study after they have completed a six week washout (free of FDA – approved or investigational anti-Alzheimer’s Disease drugs). Patients cannot enroll in this study with deficits such as blindness, severe deafness, or other disability that could limit participation. Patients with known hypersensitivities to the prescribed medications and related chemicals may not enroll.

NOTE: Subjects who are already enrolled without drug free baseline assessments will be continued in the protocol; their data will be analyzed separately.



Project 4: Depression in Alzheimer's Disease Study (DAD)

To evaluate depressive symptomatology, functional status, and quality of life for patients with and without Alzheimer’s disease (AD) and their caregivers. Consenting pairs of patients and their informants will respond to questionnaires at two time points separated by three months. The specific goal is to assess the impact of depression on the course of AD and caregiver well-being.

Inclusion Criteria:

Must be women and men aged 55 to 90 of any racial or ethnic group, with a diagnosis of possible or probable Alzheimer’s Disease (AD) by NINCDS-ADRDA criteria. Patients should live with someone, or be visited regularly by a caregiver or monitor. MMSE minimum score of 10 is required. If subjects are taking antidepressant, psychotropic or anti-dementia agents at the time of enrollment, the doses of these medications must have been stable for the month prior to their baseline assessment. Antidepressants may be prescribed or doses may be changed during the three month study. Patient must have willingness to participate in the study, and sign the consent form (or have a caregiver sign).

Exclusion:

Patients cannot enroll in this study if they do not speak English.

The length of each evaluation is approximately 2 hours because the patient and informant are interviewed separately.



Project 5: Frontotemporal Dementia Consortium

The purpose of this project is to establish a standardized database and data collection system for the study of patients with frontotemporal dementia (FTD) through a Consortium of the ARCCs. Frontotemporal dementia patients will be compared to conventional AD patients (CAD), AD patients with executive dysfunction (frontal variant AD; FAD), and healthy controls on neuropsychological tests and caregiver measures.

USC Site: CAD and FAD patients will be evaluated at USC.

Inclusion Criteria:

Subjects must be between the ages of 35-80 and meet criteria for either FTD, AD, or normal control. Each participant must have a reliable informant who has frequent contact with the subject and is available to provide information about the subject’s functional abilities to be included in the study. FTD and AD patients will also be required to have a caregiver that can provide behavioral information on the subject. The informant and caregiver may in some cases be the same person. Because the normal controls will not have caregivers the informant will be used for both the functional and behavioral assessments. Subjects will be asked to have their informant and/or caregiver accompany them to their research visits or for an alternative method of contact (i.e. telephone, mail, etc.).

Exclusion Criteria:

Exclusion criteria are: a) History of Korsakoff syndrome, alcohol dependence (within 5 years of dementia onset), substance abuse, head trauma (with loss of consciousness > 30 min), brain tumor, multiple sclerosis, epilepsy, parkinsonism (which predates dementia onset by 1 year), ALS, schizophrenia, bipolar, brain hemorrhage, b) Current history of B12 deficiency, hypothyroidism (TSH>150% normal), HIV positivity, renal failure (creatinine>2), liver failure (AST>2x normal), respiratory failure, unipolar depression, dementia due to other causes than FTLD or AD, serious systemic medical illnesses, c) Medications which affect CNS function: benzodiazepines (> 3 x per week), antidepressants (no amitriptyline; Selective Serotonin Reuptake inhibitors and other tricyclics OK), lithium, neuroleptics in phenothiazine and haloperidol families, anticonvulsant (outside therapeutic range), antihistamines (> 3 x week; must be held 24 hours before neuropsychological tests).