# BEHAVIORAL AND PSYCHOTIC SYMPTOMS IN ALZHEIMER'S DISEASE

> **NIH NIH R01** · NEW YORK UNIVERSITY · 1992 · $222,369

## Abstract

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.

## Key facts

- **NIH application ID:** 3120899
- **Project number:** 5R01AG009127-03
- **Recipient organization:** NEW YORK UNIVERSITY
- **SAM.gov UEI:** NX9PXMKW5KW8
- **Principal Investigator:** Barry Reisberg
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 1992
- **Award amount:** $222,369
- **Award type:** 5
- **Project period:** 1990-05-01 → 1995-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/3120899

## Citation

> US National Institutes of Health, RePORTER application 3120899, BEHAVIORAL AND PSYCHOTIC SYMPTOMS IN ALZHEIMER'S DISEASE (5R01AG009127-03). Retrieved via MORVS 2026-10-25 from https://api.morvs.ai/grant/nih/3120899. Licensed CC0.

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