Eligibility, any sex, with Alzheimer's Disease or Disruptive Behavior. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
ADCS-Clinical Global Impression of Change in Agitation (ADCS-CGIC-A)Primary· From Baseline through Week 12.
The ADCS-CGIC-A is the primary outcome measure. It will be anchored to disruptive agitation, the target behaviors in this study. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a direct examination of the participant and an interview of the participant's primary caregiver and other LTC facility staff. The baseline assessment is qualitative therefore there is no score at baseline; post-baseline scores represent a change score compared to baseline.
The ADCS-CGIC-A is a 7-point scale that is structur
Group
Value
95% CI
Treatment (Prazosin)
3.434
± 0.2833
Placebo Oral Capsule
3.442
± 0.6141
Neuropsychiatric Inventory (NPI)/Neuropsychiatry Inventory-Nursing Home Version (NPI-NH)Secondary· 12 weeks
The NPI was designed to characterize the neuropsychiatric symptoms and psychopathology of patients with AD and other dementias residing in the community about which information was obtained from family caregivers. The content of the questions and their scoring in the NPI-NH are identical to those of the NPI except for some slight rephrasing to be consistent with the LTC environment where information is gathered from professional caregivers. Assessment of the impact of behavioral disturbances on family and professional caregivers, is assessed by a caregiver distress scale in the NPI and an occu
Group
Value
95% CI
Treatment (Prazosin)
-6.033
± 4.692
Placebo Oral Capsule
5.506
± 10.149
Rescue Medication: Total mg Lorazepam AdministeredSecondary· 12 weeks
Cumulative total dose of Lorazepam rescue medication administered during the trial. Information on the total mg rescue lorazepam administered will be collected as additional secondary outcome measures. If prazosin is more effective than placebo, it is predicted that participants randomized to prazosin will be prescribed lower cumulative mg of rescue lorazepam for management of persistent or worsening disruptive agitation.
Group
Value
95% CI
Treatment (Prazosin)
0.25
± 0.69
Placebo Oral Capsule
0.14
± 0.24
Study DiscontinuationsSecondary· 12 weeks
Cox proportional hazard modelling comparing the median time to drop out between treatment groups.
Group
Value
95% CI
Treatment (Prazosin)
65.63
± 32.63
Placebo Oral Capsule
54.62
± 33.29
Responder Analysis on CGIC-ASecondary· 12 weeks
Comparison of proportions of responders versus non responders on the ADCS-CGIC-A. Responders are defined as those with moderate or marked improvement in agitation symptoms compared to baseline assessment.
Group
Value
95% CI
Treatment (Prazosin)
7
Placebo Oral Capsule
1
ADCS-ADL-SevereSecondary· 12 weeks
The ADCS-ADL-Severe questionnaire is a secondary outcome measure aimed at detecting functional decline in people with severe AD. This scale is best suited for evaluating people with MMSE scores below 15/30, or equivalent. Questions are administered to a qualified caregiver informant about a set of 19 basic and instrumental ADL. Instrumental ADL are selected to be relevant to this level of severity of dementia, e.g., obtaining a beverage, turning lights on and off, turning a faucet on and off. Performance of each of these activities during the past 4 weeks, as well as the level of performance,
Group
Value
95% CI
Treatment (Prazosin)
-1.47055
± 1.0062
Placebo Oral Capsule
-4.53993
± 2.1863
Caregiver Distress on NPI/NPI-NHSecondary· 12 weeks
Comparison of effects on caregiver distress/occupational disruptiveness scores on the NPI/NPI-NH. Minimum score is 0 and maximum score is 60. A higher score is a worse outcome.
This outcome is the change from baseline to week 12.
Group
Value
95% CI
Treatment (Prazosin)
-2.4438
± 2.332
Placebo Oral Capsule
0.9446
± 5.043
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected from signed consent through the participant duration in the study. The specific time period is from consent through the end of the 12 week double-blind trial..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study evaluates the effects of Prazosin on agitation in adults with Alzheimer's disease.
Two thirds of the participants will participate in the medication portion, while one third will participate in the placebo portion
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05189977 — A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline
· Phase 1
· terminated
NCT04793685 — Prazosin for Alcohol Use Disorder With Withdrawal Symptoms
· Phase 2
· recruiting
NCT03997864 — Administration of Prazosin to Prevent PTSD in Adult Women After Sexual Assault
· Phase 4
· withdrawn
NCT03539614 — Predicting Responses to PTSD Treatment With Iris and Cardiovascular Tests
· Phase 3
· active not recruiting
Other recruiting trials for Alzheimer's Disease
Currently open trials in the same condition.
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NCT07214727 — A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
· Phase 1
· recruiting
NCT07105709 — Open-label Extension Study in Participants With Early Alzheimer's Disease
· Phase 2
· recruiting
Other Alzheimer's Disease Cooperative Study (ADCS) trials
Trials by the same sponsor.
NCT06223360 — A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)
· Phase 2
· recruiting
NCT05350410 — "Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia Program"
· NA
· completed
NCT02814526 — Exercise in Adults With Mild Memory Problems
· NA
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alzheimer's Disease Cooperative Study (ADCS)
Last refreshed: 6 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03710642.