INTERVENTIONS TO MANAGE ALZHEIMER'S DISEASE SYMPTOMS

NIH GUIDE, Volume 21, Number 7, February 21, 1992



RFA AVAILABLE:  NR/AG-92-03



P.T. 34



Keywords:

  Senile Dementia 

  Behavioral Medicine 

  Behavioral/Experimental Psychology 



National Center for Nursing Research

National Institute on Aging



Letter of Intent Receipt Date:  May 1, 1992

Application Receipt Date:  June 10, 1992



THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS

ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION.  POTENTIAL

APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACTS NAMED IN INQUIRIES

BELOW.



PURPOSE



The National Center for Nursing Research (NCNR) and the National

Institute on Aging (NIA) invite research grant applications for

preliminary investigations that will lead to large-scale clinical

studies on the assessment and nonpharmacological management of

secondary symptoms exhibited by patients with Alzheimer's disease and

related disorders (AD).



HEALTH PEOPLE 2000



The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  This RFA,

Interventions to Manage Alzheimer's Disease Symptoms, is related to the

priority areas of older persons as a targeted group and to chronically

disabling conditions.  Potential applicants may obtain a copy of the

"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0 or

Summary Report:  Stock No. 017-001-00473-1) through the Superintendent

of Documents, Government Printing Office, Washington, DC 20402-9325

(telephone 202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by domestic and foreign for-profit and

non-profit organizations, public and private, such as universities,

colleges, hospitals, laboratories, units of State or local governments,

and eligible agencies of the Federal Government.  Applications from

minority individuals and women are encouraged.



MECHANISM OF SUPPORT



This RFA will use the National Institutes of Health (NIH) individual

research grant (R01).  Responsibility for the planning, direction, and

execution of the proposed project will be solely that of the applicant.

The total project period for applications submitted in response to the

present RFA may not exceed three years.  This RFA is a one-time

solicitation.  Future unsolicited competing continuation applications

will compete with all investigator-initiated applications and be

reviewed according to the customary peer review procedures.  The

anticipated award date will be September 30, 1992.



FUNDS AVAILABLE



Approximately $1,300,000 in total costs for the first year will be

committed to fund applications submitted in response to this RFA.  It

is anticipated that 13 applications will be funded.  This level of

support is dependent on the receipt of a sufficient number of

applications of high scientific merit.  Up to $75,000 direct costs will

be allocated for each award in each funding year, not to exceed three

years.  Although this program is provided for in the financial plans of

the NCNR and the NIA, awards pursuant to this RFA are contingent upon

the availability of funds for this purpose.





RESEARCH OBJECTIVES



Estimates indicate that 4 million Americans presently suffer from AD.

The impact of AD on patients, families, and society is severe and is

anticipated to grow as older persons, the group most at risk for AD,

continue to increase in number.  Although it may not yet be possible to

prevent, treat, or permanently alter the course of the underlying

disease, interventions can be developed and systematically tested that

reduce the patient's secondary symptoms and preserve function.  In

addition to cognitive symptoms, non-cognitive secondary symptoms are

frequently seen across the course of Alzheimer's disease and present

significant management problems.  These symptoms of special concern may

include, but are not limited to, wandering, disturbed sleep, pacing,

agitation, feeding and dressing difficulties, incontinence and

toileting difficulties, screaming and other vocalizations, aggression

and violence, and inappropriate sexual behavior.  These symptoms not

only contribute to decisions to institutionalize affected individuals,

but also lead to the use of chemical and physical restraints.



While there exists a great deal of clinical and anecdotal information

about methods that can effectively deal with individual symptoms,

little data exist that have been obtained with the rigor of design and

procedures of the controlled clinical trial.  Therefore, applications

are solicited for preliminary investigations and feasibility studies of

protocols that will lay the groundwork for the development of rigorous

controlled clinical trials to test interventions for the management of

the secondary symptoms.



These preliminary studies may address any of the scientific assessment,

design, methodological, and intervention problems to facilitate the

launch of large-scale clinical trials.  For example, satisfactory

assessment techniques and instruments for addressing the previously

noted problematic symptoms are needed.  Studies are needed of

strategies for enhancing AD patients' self-care abilities.  Delineation

of appropriate interventions for an individual symptom or cluster of

symptoms and methods for implementing the interventions must be

identified.  In particular, attention is needed to the affected

person's past daily practices and preferences in order to adjust care

to such characteristics.  Although the primary focus is on

nonpharmacologic interventions, research is also needed that addresses

the multimodal treatment approaches including, but not limited to,

pharmacological interventions for managing symptoms.  Studies

addressing only pharmacological interventions are not acceptable.



Information on the acceptability, safety, and rationale for the

effectiveness of interventions must be obtained prior to undertaking

any large-scale trial.  Carefully developed interventions for testing

in controlled clinical trials at long-term care institutions are

needed.  Procedures for maintaining interventions across the duration

of the trial, using existing nursing home staff, are not clear.

Therefore, behavioral, environmental, social, and organizational

interventions, individually or in combination, may be proposed and

examined.  The research may address patient issues in either

institutional or noninstitutional settings.  Either formal or informal

caregivers may be included in the research, but outcome measures must

include one or more patient variables.  Studies that address the

interrelatedness of the biological, behavioral, and cognitive factors

of patients are encouraged.



Applications are invited to support projects that address issues

including, but not limited to:



o  the identification of underlying factors in research subjects that

result in behavioral symptoms and interventions to address these

factors.



o  the design and testing of interventions that will lead to the

nonpharmacologic management and treatment of the secondary symptoms

exhibited by patients with AD.



o  provision of a rigorous scientific base that will lead to controlled

clinical trials in institutional or noninstitutional settings by

delineating approaches for the management of symptoms, the duration of

change, and the procedures required to maintain the change, if

possible.



SPECIAL INSTRUCTIONS TO REGARDING INCLUSION OF WOMEN AND MINORITIES IN

CLINICAL RESEARCH STUDIES



For projects involving clinical research, NIH requires applicants to

give special attention to the inclusion of women and minorities in

study populations.  If women or minorities are not included in the

study populations for clinical studies, a specific justification for

this exclusion must be provided.  Applications without such

documentation will not be accepted for review.



LETTER OF INTENT



Prospective applicants are asked to submit by May 1, 1992, a letter of

intent that includes a descriptive title of the proposed research, the

name, address, and telephone number of the Principal Investigator, the

identities of other key personnel and participating institutions, and

the number and title of the RFA in response to which the application is

being submitted.



Although a letter of intent is not required, is not binding, and does

not enter into the review of subsequent applications, the information

that it contains is helpful in planning for the review of applications.

It allows the NCNR and NIA staff to estimate the potential review

workload and to avoid conflict of interest in the review.



The letter of intent is to be sent to:



Ethel B. Jackson, D.D.S.

Chief, Office of Scientific Review

National Center for Nursing Research

Building 31, Room 5B19

Bethesda, MD  20892

Telephone:  (301) 496-0472

FAX:  (301) 480-4969



APPLICATION PROCEDURES



The RFA contains important information for applicants and may be

obtained from the contacts listed in the INQUIRY section.  The

application receipt date is June 10, 1992.  The research grant

application form PHS 398 (rev. 9/91) is to be used in applying for

these grants.  These forms are available at most institutional business

offices and from the Office of Grants Inquiries, Division of Research

Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449,

Bethesda, MD 20892 telephone 301/496-7441.  Applications must be

submitted to the NIH Division of Research Grants and will be assigned

to a special review group organized by NCNR and NIA.  Following this

review, applications will be considered by the national advisory

councils.



REVIEW CONSIDERATIONS



Upon receipt, applications will be reviewed by NIH staff for

completeness and responsiveness.  Incomplete applications will be

returned to the applicant without further consideration.  If the

application is not responsive to the RFA, NCNR or NIA staff will

contact the applicant to determine whether to return the application to

the applicant or submit it for review in competition with unsolicited

applications at the next review cycle.



Those applications that are complete and responsive will be evaluated

in accordance with the criteria stated below for scientific/technical

merit by an appropriate peer review group convened by NCNR and NIA.

The second level of review will be provided by the NCNR and NIA

advisory councils.



INQUIRIES



Written and telephone inquiries concerning this RFA are encouraged and

are to be directed to either of the following individuals.  The program

staff welcome the opportunity to clarify any issues or questions from

potential applicants.



Direct inquiries regarding programmatic issues to either:



Mary D. Lucas, Ph.D., R.N.

Chief, Acute and Chronic Illness Branch

National Center for Nursing Research

Westwood Building, Room 754

Bethesda, MD  20892

Telephone:  (301) 496-0523



Teresa S. Radebaugh, Sc.D.

Chief, Dementias of Aging

Neuroscience and Neuropsychology of Aging

National Institute on Aging

Gateway Building, Room 3C307

7201 Wisconsin Avenue

Bethesda, MD  20892

Telephone:  (301) 496-9350



Direct inquiries regarding fiscal matters to:



Sally A. Nichols

Grants Management Officer

National Center for Nursing Research

Building 31, Room 5B06

Bethesda, MD  20892

Telephone:  (301) 496-0237



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

No. 93.336, Nursing Research, and No. 93.866.  Awards are made under

authorization of the Public Health Service Act, Title IV, Part A

(Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and

285) and administered under PHS grants policies and Federal Regulations

42 CFR 52 and 45 CFR Part 74.  This program is not subject to the

intergovernmental review requirements of Executive Order 12372 or

Health Systems Agency review.



.

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