Selected Ongoing Clinical Trials [*].

1. PAIN MANAGEMENT AND BEHAVIORAL OUTCOMES IN PATIENTS WITH DEMENTIA.

This is a Phase II, double-blind, placebo-controlled, cross-over design trial to elucidate the relationships between pain, discomfort, and agitation and determine the influence that pain management has on decreasing discomfort, agitation, and confusion in, nursing home residents. Eligibility criteria include: men and women aged 55 years and older who are nursing home residents with a diagnosed painful condition that would respond to Tylenol; who have documented agitated behavior; a dementia diagnosis of a function impairment severe enough to rate a seven on the Global Deterioration Scale; and are unable to report pain. Patients must also have been residents in a nursing home for at least one month with plans to stay at least two months.

2. PREVENTING COGNITIVE DECLINE WITH ALTERNATIVE THERAPIES.

This Phase III, double-blind, placebo-controlled, randomized controlled trial is an initial 42-month study of the effect of standardized Ginkgo biloba extract on preventing or delaying cognitive decline in people aged 85 years or older. Both men and women aged 85 years and older who can identify a collateral informant who has frequent contact with the subject, have normal memory function defined by an education-adjusted score on the Logical Memory Subscale of the Wechsler Memory Scale Revised, have a Clinical Dementia Rating of zero, and a Mini-Mental State Examination Score [greater than]23 are eligible.

3. THE EFFECTS OF SEX HORMONES ON COGNITION AND MOOD IN OLDER ADULTS.

This double-blind, placebo-controlled, crossover design study will investigate the effects of hormone replacement therapy on memory, mental abilities, and mood in older adults aged 65-90 years. Both males and females who have not received hormone replacement therapy for the last three months are eligible.

4. RANDOMIZED STUDY OF TWO INTERVENTIONS FOR LIQUID ASPIRATION: SHORT-TERM AND LONG-TERM EFFECTS.

This Phase III, multicenter, randomized control study will determine whether chin-down posture or use of a thickened liquid diet is more effective in the prevention of aspiration and aspiration pneumonia in patients with Parkinson's disease and/or dementia. Both men and women aged 50-95 years with dementia or Parkinson's disease who aspirate on thin liquid during a set of qualifying swallows are eligible.

5. ALZHEIMER'S DISEASE PREVENTION TRIAL.

This Phase III, double-blind, randomized, placebo-controlled study will determine whether estrogen delays memory impairment or onset of Alzheimer's disease in women over the age of 65 years who have a positive family history. Healthy women with a family history of memory problems not currently on estrogen are eligible.

Contact: Alba Ragnaugth, Research Assistant, 630 W 168 St, P&S Box 16, New York, NY 10032. [phone]. E-mail: raghnau@sergievsky. cpmc.columbia.edu

6. TREATMENT OF BEHAVIORAL SYMPTOMS IN ALZHEIMER'S DISEASE.

This Phase I and Phase II double-blind, placebo-controlled, randomized controlled trial will use haloperidol to treat behavioral symptoms in Alzheimer's disease patients for both men and women who meet DSM-IV criteria for dementia or MINCDS/ADRDA criteria for probable Alzheimer's disease. Individuals who meet the above criteria and have reported intellectual impairment for at least six months are eligible.

Contact: Gregory Pelton, MD, New York State Psychiatric Institute, 722 W 168th St, Unit 126, New York, NY 10032. [phone]. E-mail [e-mail]

7. THE DEPRESSION IN ALZHEIMER'S DISEASE STUDY (DIADS).

This is a Phase IV, 13-week, double-blind, flexible dose, placebo-controlled trial of sertraline to treat outpatients with Alzheimer's disease and co-morbid major depression. Both men and women who meet NINCDS/ADRDA criteria with a Mini-Mental State Examination score greater than 10, and a diagnosis of current major depressive episode are eligible.

Contact: Susan Kopunek, RN, Johns Hopkins University, Baltimore, MD 21224. [phone].

8. ALZHEIMER'S DISEASE ANTI-INFLAMMATORY PREVENTION TRIAL (ADAPT).

This Phase III interventional, prevention, double-blind, placebo-controlled, randomized controlled trial will test the ability of the nonsteroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of Alzheimer's disease (AD) and agerelated cognitive decline. Both men and women aged 70 years and older with a family history of a parent, brother, or sister who has, or had, serious age-related memory loss, senility, dementia, or AD are eligible.

Contact: Julia Pedroso, RN, Johns Hopkins University, Baltimore, MD 21287. E-mail: [e-mail]

9. ESTROGEN EFFECTS ON MEMORY FUNCTIONING IN POSTMENOPAUSAL WOMEN AND PATIENTS WITH ALZHEIMER'S DISEASE.

This is a Phase II treatment, double-blind, placebo-controlled trial that will examine whether three months of estrogen given to post-menopausal women and women with mild to moderate Alzheimer's disease concurrently treated with standard therapy will enhance the system in the brain which involves memory and learning. Women aged 45 years and older with mild Alzheimer's disease and normal volunteers are eligible.

Contact: Katie Hancur, MS, UHC Campus, Arnold 6, 1 South Prospect St, Burlington, VT 05401. [phone]. E-mail: Catherine.Hancur@ vtmednet.org

10. A MULTICENTER TRIAL OF ROFECOXIB AND NAPROXEN IN ALZHEIMER'S DISEASE.

This Phase II and Phase III treatment, double-blind, multicenter study, placebo-controlled trial, random allocation, randomized control study will test if non-steroidal anti-inflammatory drugs slow the rate of cognitive deterioration. Both men and women aged 55 years and older who meet NINCDS/ADRDA criteria for probable Alzheimer's disease are eligible.

Contact: Judith Lawrence, RNC, Barrow Neurological Group, 500 West Thomas Rd, Suite 700, Phoenix, AZ 85013. [phone]. E-mail. [e-mail]

11. NEFIRACETAM IN THE TREATMENT OF ALZHEIMER'S DISEASE.

This Phase II clinical trial will test whether nefiracetam can safely improve memory, thinking and activities of daily living in patients with mild to moderate intellectual impairment due to Alzheimer's disease (AD). Both men and women who satusft NINCDS-ADRDA criteria for probable AD are eligible.

Contact: National Institute of Neurological Disorders and Stroke, 9000 Rockville Pike, Bethesda, MD 20892. [phone]. E-mail: [e-mail]

12. TREATMENT OF ALZHEIMER'S DISEASE WITH CX516 (AMPALEX).

This Phase II clinical trial will assess if giving patients a drug that attaches to special sites on cells improves the symptoms of Alzheimer's disease (AD). Both men and women aged 55 to 85 years with probable AD are eligible.

Contact: National Institute of Neurological Disorders and Stroke, 9000 Rockville Pike, Bethesda, MD 20892. [phone]. E-mail: [e-mail]

13. SEROTONERGIC PHARMACOTHERAPY FOR AGITATION OF DEMENTIA.

This Phase III interventional, double-blind, placebo-controlled, randomized controlled trial will test citalopram and perphenazine for treatment of emotional and behavioral disturbances that may accompany dementia. Both men and women who meet DSM-IV criteria for a diagnosis of dementia of the Alzheimer's type, vascular dementia, mixed, or dementia not otherwise specified are eligible.

Contact: Kimberly A. Huber, University of Pittsburgh, Western Psychiatric Institute and Clinic, Pittsburgh, PA 15213. [phone]. E-mail: [e-mail]

14. GINKGO BILOBA PREVENTION TRIAL IN OLDER INDIVIDUALS.

This Phase III multicenter study, randomized control study will compare Ginkgo biloba to a placebo in preventing dementia in healthy men and women at least 75 years old. Participants who are non-demented, willing to participate in a six-year follow-up trial of Ginkgo biloba and speak English as a primary language are eligible.

Contact: Dr. Steven DeKosky, Western Psychiatric Institute and Clinic of UPMC, 3811 O'Hara St, Pittsburgh, PA 15213. [phone]. E-mail: [e-mail]

15. THE EFFECT OF ACETYLCHOLINE ON MEMORY AND ATTENTION.

This natural history study will examine whether enhancing the chemical acetylcholine in the brain can improve memory and attention. Both men and women aged 45 to 100 years with Alzheimer's disease, healthy controls aged 20 to 50 years, and healthy controls aged 50 to 90 years are eligible.

Contact: National Institute of Mental Health, 9000 Rockville Pike, Bethesda, MD 20892. [phone]. E-mail: [e-mail]

16. DIAGNOSIS AND NATURAL HISTORY STUDY OF PATIENTS WITH NEUROLOGICAL CONDITIONS.

This natural history study will provide a diagnosis and follow-up to patients not currently entered on another research protocol. Both men and women who have an identifiable neurological disorder or present a diagnostic puzzle are eligible.

Contact: National Institute of Neurological Disorders and Stroke, 9000 Rockville Pike, Bethesda, MD 20892. [phone]. E-mail: [e-mail]

17. THE EVALUATION AND FOLLOW-UP OF PATIENTS WITH MEMORY DISORDER AND NORMAL VOLUNTEERS.

This history study will screen patients with memory problems and normal volunteers to determine if they can be included in other research studies as patients or controls. Patients will undergo annual tests to determine cognitive ability. Both men and women with memory problems and normal volunteers aged 85 years and older are eligible.

Contact: National Institute of Mental Health, 9000 Rockville Pike, Bethesda, MD 20892. [phone]. E-mail: [e-mail]

18. BRAIN STUDY OF PATIENTS WITH FRONTAL LOBE DEMENTIA AND PARKINSONIAN DISORDERS.

This natural history study will continue cross-sectional and longitudinal studies of cerebral metabolism in frontal lobe dementias and atypical basal ganglia disorders. Both men and women with frontotemporal dementia and atypical basal ganglia disorders are eligible.

Contact: National Institute of Neurological Disorders and Stroke, 9000 Rockville Pike, Bethesda, MD 20892. [phone]. E-mail: [e-mail]

19. ANTI-INFLAMMATORY TREATMENT FOR AGE-ASSOCIATED MEMORY IMPAIRMENT: A DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL.

This Phase III interventional treatment, double-blind, placebo-controlled, randomized controlled trial will study whether anti-inflammatory drugs, such as ibuprofen, delay age-related mental decline. Both men and women aged 65 to 90 years with age-associated memory impairment with low scores on tests of verbal and visual memory and verbal fluency are eligible.

Contact: Andrea Kaplan, UCLA Neuropsychiatric Institute, 760 Westwood Plaza, University of California -- Los Angeles, Los Angeles, CA 90024. [phone]. E-mail: [e-mail]

(*.) Prepared by Elaine McLellan-Holm.