A Study of the Safety and Efficacy of Pimavanserin in Patients With Alzheimer's Disease Psychosis

NCT02035553 | Completed Phase 2 Results DMC

• 1 other identifier: ACP-103-019
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of pimavanserin 40 mg compared to placebo in patients with Alzheimer's disease psychosis.

Conditions

Alzheimer's Disease Psychosis

Outcome Measures

Primary Outcomes (1)

• Antipsychotic Efficacy

  Change from Baseline to Day 43 in the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) psychosis score (Delusions \[Domain A\]+Hallucinations \[Domain B\]) in the Full Analysis Set (FAS). The NPI-NH is a questionnaire that quantifies behavioral changes in dementia in nursing home patients and evaluates 12 behavioral domains. For each of the 12 behavioral domains the Frequency (scale:1=occasionally to 4=very frequently) is multiplied by the Severity (scale:1=Mild to 3=Severe) to obtain a domain score (frequency x severity), The NPI-NH Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual domain scores, to yield a possible total score of 0 to 24. Lower scores correspond to less severity. A negative change score from baseline indicates improvement.

  Day 43

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo, two tablets, once daily by mouth

Drug: Placebo

Pimavanserin 40 mg

EXPERIMENTAL

Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)

Drug: Pimavanserin tartrate

Interventions

Pimavanserin tartrate DRUG

Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)

Also known as: ACP-103

Pimavanserin 40 mg

Placebo DRUG

Placebo, two tablets, once daily by mouth

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be 50 years of age or older with NINCDS-ADRDA defined possible or probable AD
• Patient must have psychotic symptoms that developed after the diagnosis of AD was established. These symptoms must include visual and/or auditory hallucinations, and/or delusions
• Patient must have been a nursing home resident for ≥ 4 weeks prior to randomization, not bedridden and expected to remain in the facility throughout the study
• Patient must have actively experienced and verbally communicated psychotic symptoms during the month prior to the Screening visit and weekly during the previous 2 weeks prior to Baseline
• If patient is on acetylcholinesterase inhibitor (AChEI) therapy and/or memantine, must be on stable doses for 3 months prior to the Baseline visit and during the study
• Patient is willing and able to provide informed consent. If the subject is unable to provide written consent due to the severity of dementia, consent must be given by a legally authorized representative

You may not qualify if:

• Patient has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Alzheimer's disease including, but not limited to, schizophrenia or bipolar disorder
• Patient is unable to communicate verbally
• Patient has current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study
• Patient has had a myocardial infarction in the last six months
• Patient has moderate to severe congestive heart failure
• Patient has any surgery planned during the screening, treatment, or follow-up periods that could interfere with participation in the study per the protocol assessments
• Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (1)

Unknown Facility

London, United Kingdom

Location

Related Publications (2)

• Muhlbauer V, Mohler R, Dichter MN, Zuidema SU, Kopke S, Luijendijk HJ. Antipsychotics for agitation and psychosis in people with Alzheimer's disease and vascular dementia. Cochrane Database Syst Rev. 2021 Dec 17;12(12):CD013304. doi: 10.1002/14651858.CD013304.pub2.

  PMID: 34918337 DERIVED

• Ballard C, Banister C, Khan Z, Cummings J, Demos G, Coate B, Youakim JM, Owen R, Stankovic S; ADP Investigators. Evaluation of the safety, tolerability, and efficacy of pimavanserin versus placebo in patients with Alzheimer's disease psychosis: a phase 2, randomised, placebo-controlled, double-blind study. Lancet Neurol. 2018 Mar;17(3):213-222. doi: 10.1016/S1474-4422(18)30039-5.

  PMID: 29452684 DERIVED

MeSH Terms

Interventions

pimavanserin

Results Point of Contact

• Title: James Youakim, Vice President, Clinical Development
• Organization: ACADIA Pharmaceuticals Inc.

jyouakim@acadia-pharm.com

609-250-6900

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 14, 2014
• Study Start: November 1, 2013
• Primary Completion: September 28, 2016
• Study Completion: October 27, 2016
• Last Updated: October 25, 2017
• Results First Posted: October 25, 2017

Record last verified: 2017-09

Locations

GB (1)