Alzheimer's in Long-Term Care--Treatment for Agitation

NCT00161473 | Completed Results DMC

• 3 other identifiers: 16508-A5R01AG0186445P50AG005136
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if a medication called prazosin is useful in the treatment of agitation and aggression in persons with Alzheimer's disease (AD) and other types of dementia in late life.

Conditions

Alzheimer Disease; Psychomotor Agitation

Keywords

double-blind; treatment; prazosin

Outcome Measures

Primary Outcomes (2)

• Mean Clinical Global Impression of Change (CGIC) at Last Observation

  The Clinical Global Impression of Change (CGIC) is a 7 point scale, where 1 indicates "markedly improved," 4 indicates "no change," and 7 indicates "markedly worse."

  Week 8

• Change in Neuropsychiatric Inventory (NPI) Total Score Over the Course of Study Participation

  The Neuropsychiatric Inventory (NPI) is a 12-item scale that assesses the frequency and severity of behavioral symptoms in patients with dementia. Each Neuropsychiatric Inventory item ranges from 0 to 12. Therefore the Neuropsychiatric Inventory total score has a minimum total value of 0 and maximum 144, where 144 indicates higher levels of behavioral symptoms. A change in Neuropsychiatric Inventory total score that is a negative number (that is, an Neuropsychiatric Inventory score decrease), indicates behavioral improvement.

  Weeks 2, 4, 6, and 8 (change from Baseline)

Secondary Outcomes (2)

• Number of Behavioral Assessment Visits Completed

  Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8)

• Change in Brief Psychiatric Rating Scale (BPRS) Total Score Over the Course of Study Participation

  Weeks 2, 4, 6, and 8 (change from Baseline)

Study Arms (2)

prazosin

ACTIVE COMPARATOR

Drug: prazosin

placebo (inert substance)

PLACEBO COMPARATOR

Drug: placebo (inert substance)

Interventions

prazosin DRUG

Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime. Duration was 8 weeks.

Also known as: Minipress

prazosin

placebo (inert substance) DRUG

Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials. Duration is 8 weeks.

placebo (inert substance)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• No age limit
• probable/possible Alzheimer's disease diagnosis
• disruptive agitated behaviors (e.g., irritability, aggression, uncooperativeness, pacing)
• no hypotension
• no concurrent use of alpha-1-blockers
• no delirium, schizophrenia, mania, psychotic symptoms.

You may not qualify if:

• Cardiovascular: unstable angina, recent myocardial infarction, second or third degree atrioventricular (AV) block, preexisting hypotension (systolic blood pressure less than 110) or orthostatic hypotension
• Current enrollment in a separate investigational drug trial
• Psychoactive medications: subjects may be psychoactive medication-free or be partial responders (by subjective assessment of referring health care professional) to one psychoactive medication from any of the following classes: antipsychotics, anticonvulsants, mood stabilizers, antidepressants, benzodiazepines, or buspirone. Partial response is defined as some improvement in agitated behavior but persistence of agitated behaviors severe enough to cause patient distress and/or difficulty with caregiving. Although not formally rated, this improvement is equivalent to a Clinical Global Impression of Change (CGIC) rating of no more than minimal improvement (improvement is noticed by not enough to improve patient function or caregiver's practical management of the patient).
• Psychiatric/behavioral: lifetime schizophrenia; current delirium, mania, depression, or uncontrolled persistent distressing psychotic symptoms (hallucinations, delusions), substance abuse, panic disorder, or any behavior which poses an immediate danger to patient or others or which results in the patient being too uncooperative to meet the requirements of study participation.

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Veterans Affairs Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related Publications (1)

• Wang LY, Shofer JB, Rohde K, Hart KL, Hoff DJ, McFall YH, Raskind MA, Peskind ER. Prazosin for the treatment of behavioral symptoms in patients with Alzheimer disease with agitation and aggression. Am J Geriatr Psychiatry. 2009 Sep;17(9):744-51. doi: 10.1097/JGP.0b013e3181ab8c61.

  PMID: 19700947 RESULT

MeSH Terms

Conditions

Alzheimer Disease; Psychomotor Agitation

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Lucy Y. Wang, M.D.
• Organization: VA Puget Sound Healthcare System

wanglucy@u.washington.edu

206-277-5089

Study Officials

• Elaine R Peskind, MD

  Veterans Affairs Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 2001
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 2, 2012
• Results First Posted: August 2, 2012

Record last verified: 2012-06

Locations

US (1)