Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2018-10-23
2022-01-05
Brief Summary
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Two thirds of the participants will participate in the medication portion, while one third will participate in the placebo portion
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Detailed Description
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Distruptive agitation defined as having one or more of the following behaviors nearly daily during the previous week and at least intermittently for four weeks prior to screening: a) irritability, b) physically and/or verbally aggressive behavior, c) physically resistive to necessary care, d) and/or pressured motor activity (e.g., pressured pacing).
LTC is defined as assisted living or skilled nursing facility. Home dwelling participants require full-time caregiving defined as having continuous daily caregiving and a Study Partner who will assist in providing protocol specific information to the study team.
A previous single site pilot study addressing disruptive agitation in 22 predominantly LTC-residing AD participants demonstrated efficacy of prazosin on all three primary outcome measures.1 The current multicenter study is funded by the National Institute on Aging (NIA), and coordinated through the NIA-funded Alzheimer's Disease Cooperative Study (ADCS).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment (Prazosin)
Eligible participants will be randomized using a 2:1 schedule to prazosin or placebo and stratified by site and gender, and will follow a fixed titration scheme for the first 15 days, followed by a flexible does titration from days 15-29, then a maintenance phase stable dose from days 29 to the end of the 12 weeks study period.
Prazosin Fixed titration dose schedule for Days 1 to 14 1 mg QHS for Days 1 to 3
1 mg QAM and 1 mg QHS for days 4 to 7
1. mg QAM and 2 mg QHS for days 8 to 10
2. mg QAM and 2 mg QHS for days 11 to 14
Prazosin Flexible titration dose schedule for Days 15 to 29. 3 mg QAM and 3 mg QHS on day 15, 4 mg QAM and 4 mg QHS on day 22, 4 mg QAH and 6 mg QHS on day 29,
Dose increases will be allowed only during the fixed and flexible dosing periods.
Prazosin
Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules
Placebo oral capsule
Placebo medication will be administered in a titration schedule mimicking the active comparator treatment.
Placebo oral capsule
Placebo capsule matched to appearance of active drug.
Interventions
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Prazosin
Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules
Placebo oral capsule
Placebo capsule matched to appearance of active drug.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Men and women with probable or possible AD by NINCDS-ADRDA criteria utilizing history; medical records review; physical and neurological exam; and laboratory tests (as applicable). Brain neuroimaging is not a requirement.
2. Participants must either reside in an LTC that is associated with the study site or at home with full-time caregiving.
3. Participants must have disruptive agitation significant enough to disrupt caregiving and, in the opinion of the Site Principal Investigator, to justify treatment. Disruptive agitation, defined as having any combination of the following target behaviors, must have occurred nearly daily during the previous week and at least intermittently for 4 weeks prior to screening:
1. irritability,
2. physically and/or verbally aggressive behavior,
3. physical resistiveness to necessary care
4. Psychotropic medication, if used, should be stable for at least 2 weeks prior to randomization.
5. If taking cholinesterase inhibitor and/or memantine, must be on stable dose for 3 months prior t o randomization.
6. During the week before randomization, the above-described behaviors of eligible participants must be rated as of at least moderate severity.
Exclusion Criteria
1. History of schizophrenia, schizoaffective disorder, or bipolar disorder according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM).
2. Other neurodegenerative diseases, including Parkinsons disease and Huntingtons disease, or cerebral tumor.
3. Dementia other than probable or possible AD per NINCDS-ADRDA criteria, such as human immunodeficiency virus (HIV) dementia, Creutzfeldt-Jakob disease, frontotemporal dementia, multiple cerebral infarctions, or normal pressure hydrocephalus.
4. Current treatment for seizure disorder (Note: anticonvulsants prescribed for disruptive agitation in the absence of seizure disorder will be allowed).
5. Abnormal laboratory values with clinical significance in the opinion of the site Principal Investigator.
6. Current unstable medical illness including delirium, worsening congestive heart failure, unstable angina, recent myocardial infarction (within the past 3 months), acute infectious disease, severe renal or hepatic failure, severe respiratory disease, metastatic cancer, or other conditions that, in the Site Principal Investigators opinion, could interfere with the analyses of safety and efficacy in this study.
7. Bedbound; participants may be ambulatory or use a wheelchair.
8. Absence of any comprehensible language.
9. Participation in another clinical trial for an investigational agent and took at least one dose of study drug (unless unblinded on placebo) within 12 weeks prior to screening. (The end of a previous investigational trial is defined as the date of the last dose of an investigational agent).
10. Preexisting recurrent hypotension (systolic BP \<110).
* If a reading of \<110 systolic is measured at screening,
* If the individual is taking antihypertensive medication: The Site PI should reassess the need for such medication and consider medication adjustments in consultation with the participants physician. One week following adjustment of antihypertensive(s), screening BP will be repeated for reassessment of eligibility. Further adjustment of antihypertensive medication regimen by the participants health care prescriber, may be indicated if systolic pressure remains \<110. For inclusion, new systolic measurement following medication adjustment must be ≥110.
* If the individual is not taking antihypertensive medication: repeat at least 3 BP measures over the course of 7-14 days. For inclusion, all three follow-up systolic measurements must be ≥110.
* Any systolic reading \<100 is exclusionary.
11. Preexisting orthostatic hypotension (\>20 mmHg drop in systolic BP following 2 minutes of standing posture \[or sitting if unable to stand\] and accompanied by dizziness, lightheadedness, or syncope).
12. A 2-week washout is required prior to BL for the following exclusionary medications: prazosin or other alpha-1 blocker, sildenafil, vardenafil, tadalafil, and avanafil.
13. Women of childbearing potential are not included in this study. Women of non-childbearing potential are defined as any of the following:
* have been postmenopausal (no menstrual cycle for past 24 months)
* do not have a uterus,
* have bilateral tubal ligation,
* have undergone bilateral salpingectomy, and/or bilateral oophorectomy
14. The participant may not be an immediate family member of personnel directly affiliated with this study, the study site or funding agency. Immediate family is defined as a spouse, parent, child, or sibling, any of whom may be related by blood, adoption, or marriage.
15. P articipants whom the Site Principal Investigator deems to be otherwise unsuitable for participation.
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
VA Puget Sound Health Care System
FED
Alzheimer's Association
OTHER
Alzheimer's Disease Cooperative Study (ADCS)
OTHER
Responsible Party
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Principal Investigators
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Howard Feldman
Role: PRINCIPAL_INVESTIGATOR
Alzheimer's Disease Cooperative Study (ADCS)
Locations
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Banner Sun Health Research Institute
Sun City, Arizona, United States
University of Southern California
Los Angeles, California, United States
University of California, San Diego (UCSD)
San Diego, California, United States
Alta California Medical Group
Simi Valley, California, United States
Stanford University
Stanford, California, United States
University of Kentucky
Lexington, Kentucky, United States
Northern Light/Acadia Hospital Eastern Maine Medical Center
Bangor, Maine, United States
SUNY Upstate Medical University
Syracuse, New York, United States
VAMC: James J Peters
The Bronx, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
Roper St. Francis Hospital
Charleston, South Carolina, United States
University of Texas, Health Science Center San Antonio
San Antonio, Texas, United States
University of Washington
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Peskind ER, Wingerson D, Murray S, Pascualy M, Dobie DJ, Le Corre P, Le Verge R, Veith RC, Raskind MA. Effects of Alzheimer's disease and normal aging on cerebrospinal fluid norepinephrine responses to yohimbine and clonidine. Arch Gen Psychiatry. 1995 Sep;52(9):774-82. doi: 10.1001/archpsyc.1995.03950210068012.
Torroba Alvarez L, Hermida Donate JM, Ezpeleta Baquedano C, Munoz Zato E. [Methemoglobinemia secondary to the treatment of opportunistic infections in patients with AIDS]. Rev Clin Esp. 1988 Mar;182(5):289-90. No abstract available. Spanish.
Elrod R, Peskind ER, DiGiacomo L, Brodkin KI, Veith RC, Raskind MA. Effects of Alzheimer's disease severity on cerebrospinal fluid norepinephrine concentration. Am J Psychiatry. 1997 Jan;154(1):25-30. doi: 10.1176/ajp.154.1.25.
Raskind MA, Peskind ER, Holmes C, Goldstein DS. Patterns of cerebrospinal fluid catechols support increased central noradrenergic responsiveness in aging and Alzheimer's disease. Biol Psychiatry. 1999 Sep 15;46(6):756-65. doi: 10.1016/s0006-3223(99)00008-6.
Raskind MA, Peskind ER, Hoff DJ, Hart KL, Holmes HA, Warren D, Shofer J, O'Connell J, Taylor F, Gross C, Rohde K, McFall ME. A parallel group placebo controlled study of prazosin for trauma nightmares and sleep disturbance in combat veterans with post-traumatic stress disorder. Biol Psychiatry. 2007 Apr 15;61(8):928-34. doi: 10.1016/j.biopsych.2006.06.032. Epub 2006 Oct 25.
Raskind MA, Peterson K, Williams T, Hoff DJ, Hart K, Holmes H, Homas D, Hill J, Daniels C, Calohan J, Millard SP, Rohde K, O'Connell J, Pritzl D, Feiszli K, Petrie EC, Gross C, Mayer CL, Freed MC, Engel C, Peskind ER. A trial of prazosin for combat trauma PTSD with nightmares in active-duty soldiers returned from Iraq and Afghanistan. Am J Psychiatry. 2013 Sep;170(9):1003-10. doi: 10.1176/appi.ajp.2013.12081133.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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ADC-042-PRAZ
Identifier Type: -
Identifier Source: org_study_id
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