A prospective study of possibly remediable psychotic and behavioral symptomatology in community-residing Alzheimer's disease (AD) patients will be conducted. These symptoms, which include agitation, suspiciousness, and delusional ideation, are a major cause of burden for AD caregivers and are a frequent reason for institutionalization. Although physicians are regularly called upon to treat these symptoms, limited information is available with respect to the specific nature, course and pharmacologic treatment of these symptoms. The objective of this study is to systematically evaluate and provide more definitive information on the nature, course, and treatment of these symptoms. This proposal has a longitudinal study protocol and a pharmacologic treatment protocol. A cohort of 150 subjects with AD will be assessed at 6-month intervals for 3 years; the presence or absence of specific psychotic and behavioral symptoms will be systematically evaluated. Patients who demonstrate significant behavioral symptoms will be eligible to enter a pharmacologic treatment protocol. This protocol will systematically evaluate the remediation of psychotic and behavioral symptoms in community-residing outpatients with AD, using two frequently prescribed antipsychotics (Haloperidol and Thioridazine) and one frequently prescribed antidepressant (Nortriptyline). The pharmacologic treatment protocol includes a 16-week double-blind placebo-controlled protocol and an open label maintenance protocol. Specifically, in a double-blind, parallel group design, AD patients (N = 124) with psychotic symptoms will be randomly assigned to one of four treatment groups receiving thioridazine, haloperidol, nortriptyline, or matched placebo tablets. Patients will be evaluated weekly for 16 weeks; dosage will be adjusted based on behavioral symptoms as well as side effects. Patients who complete the double-blind protocol will be treated in an open label study and seen for monthly dosage adjustments. Information will be obtained regarding efficacy, dosage, and side effects of treatment. The proposed study will provide more definitive information about the incidence, nature, and treatment course of psychotic behavioral symptoms in AD patients. The results should have direct relevance for physicians' prescribing patterns in non-institutionalized settings. The ultimate goal is to decrease the burden of AD on the caregiver.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Research Project (R01)
Project #
5R01AG009127-03
Application #
3120899
Study Section
Human Development and Aging Subcommittee 3 (HUD)
Project Start
1990-05-01
Project End
1995-04-30
Budget Start
1992-07-01
Budget End
1993-04-30
Support Year
3
Fiscal Year
1992
Total Cost
Indirect Cost
Name
New York University
Department
Type
Schools of Medicine
DUNS #
004514360
City
New York
State
NY
Country
United States
Zip Code
10012
Reisberg, Barry; Shao, Yongzhao; Golomb, James et al. (2017) Comprehensive, Individualized, Person-Centered Management of Community-Residing Persons with Moderate-to-Severe Alzheimer Disease: A Randomized Controlled Trial. Dement Geriatr Cogn Disord 43:100-117
Reisberg, Barry; Monteiro, Isabel; Torossian, Carol et al. (2014) The BEHAVE-AD assessment system: a perspective, a commentary on new findings, and a historical review. Dement Geriatr Cogn Disord 38:89-146
Reisberg, Barry; Shulman, Melanie B; Torossian, Carol et al. (2010) Outcome over seven years of healthy adults with and without subjective cognitive impairment. Alzheimers Dement 6:11-24
Reisberg, Barry; Shulman, Melanie B (2009) Commentary on ""a roadmap for the prevention of dementia II: Leon Thal Symposium 2008."" Subjective cognitive impairment as an antecedent of Alzheimer's dementia: policy import. Alzheimers Dement 5:154-6
Reisberg, Barry; Prichep, Leslie; Mosconi, Lisa et al. (2008) The pre-mild cognitive impairment, subjective cognitive impairment stage of Alzheimer's disease. Alzheimers Dement 4:S98-S108
Reisberg, Barry; Ferris, Steven H; Kluger, Alan et al. (2008) Mild cognitive impairment (MCI): a historical perspective. Int Psychogeriatr 20:18-31
Reisberg, Barry; Gauthier, Serge (2008) Current evidence for subjective cognitive impairment (SCI) as the pre-mild cognitive impairment (MCI) stage of subsequently manifest Alzheimer's disease. Int Psychogeriatr 20:1-16
Glodzik-Sobanska, Lidia; Reisberg, Barry; De Santi, Susan et al. (2007) Subjective memory complaints: presence, severity and future outcome in normal older subjects. Dement Geriatr Cogn Disord 24:177-84
Reisberg, Barry (2007) Global measures: utility in defining and measuring treatment response in dementia. Int Psychogeriatr 19:421-56
Reisberg, Barry (2006) Diagnostic criteria in dementia: a comparison of current criteria, research challenges, and implications for DSM-V. J Geriatr Psychiatry Neurol 19:137-46

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