Acadia Pharmaceuticals Initiates Phase 2 Clinical Trial of ACP-204 for the Treatment of Alzheimer’s Disease Psychosis
27 11월 2023 - 11:05PM
Business Wire
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced the
initiation of a Phase 2 study evaluating the efficacy and safety of
ACP-204 for the treatment of hallucinations and delusions
associated with Alzheimer's disease psychosis (ADP). Of the more
than 6.5 million people in the United States living with
Alzheimer’s disease (AD), approximately 30% will experience
psychosis, commonly consisting of hallucinations and
delusions.1-3
The Phase 2 study is part of a seamless Phase 2 / Phase 3
program that includes three studies: a single Phase 2 study and two
Phase 3 studies which have almost identical design. The Phase 2
study is a global, multi-center, randomized, double-blind,
placebo-controlled trial that will enroll approximately 318
patients and evaluate ACP-204 30 mg and 60 mg doses compared to
placebo. The primary endpoint is change from Baseline in the Scale
for the Assessment of Positive Symptoms–Hallucinations and
Delusions subscales (SAPS-H+D) total score at Week 6. The clinical
trial sites will enroll seamlessly from Phase 2 into Phase 3. Each
of the planned Phase 3 studies will enroll approximately 378
patients with ADP. Patients who complete the study will have the
option of participating in a long-term open-label extension (OLE)
study.
For more information about this study contact
medicalinformation@acadia.com
About Alzheimer’s Disease Psychosis
According to the Alzheimer’s Association, more than 6.5 million
people in the United States are living with Alzheimer’s disease
(AD).1,2 Approximately 30% of patients with AD experience
psychosis, commonly consisting of hallucinations and delusions.3
These symptoms may be frequent and severe and may recur over time.4
A hallucination is defined as a perception-like experience that
occurs without an external stimulus and is sensory (seen, heard,
felt, tasted, sensed, smelled) in nature. A delusion is defined as
a false, fixed belief despite evidence to the contrary. Serious
consequences have been associated with psychosis in patients with
dementia, such as increased likelihood of nursing home placement,
more severe dementia, and increased risk of morbidity and
mortality.5,6 There is no FDA-approved drug for the treatment of
Alzheimer’s disease psychosis.
About ACP-204
ACP-204 works primarily as an inverse agonist at the 5-HT2A
receptor. ACP-204 is currently being developed for the treatment of
Alzheimer's disease psychosis, for which there is a large unmet
medical need and no FDA-approved medication.
About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate
life. For 30 years we have been working at the forefront of
healthcare to bring vital solutions to people who need them most.
We developed and commercialized the first and only approved
therapies for hallucinations and delusions associated with
Parkinson’s disease psychosis and for the treatment of Rett
syndrome. Our clinical-stage development efforts are focused on
treating the negative symptoms of schizophrenia, Prader-Willi
syndrome, Alzheimer’s disease psychosis and neuropsychiatric
symptoms in central nervous system disorders. For more information,
visit us at www.acadia.com and follow us on LinkedIn and
Twitter.
Forward-Looking Statements
Statements in this press release that are not strictly
historical in nature are forward-looking statements. These
statements include but are not limited to statements regarding the
timing of future events. These statements are only predictions
based on current information and expectations and involve a number
of risks and uncertainties. Actual events or results may differ
materially from those projected in any of such statements due to
various factors, including the risks and uncertainties inherent in
drug development, approval and commercialization. For a discussion
of these and other factors, please refer to Acadia’s annual report
on Form 10-K for the year ended December 31, 2022, as well as
Acadia’s subsequent filings with the Securities and Exchange
Commission. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
This caution is made under the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. All
forward-looking statements are qualified in their entirety by this
cautionary statement and Acadia undertakes no obligation to revise
or update this press release to reflect events or circumstances
after the date hereof, except as required by law.
References
1 Alzheimer’s Association. 2023 Alzheimer’s Disease Facts and
Figures. Alzheimers Dement 2023;19(4). 2 Rajan KB et al. Population
estimate of people with clinical Alzheimer’s disease and mild
cognitive impairment in the United States (2020-2060). Alzheimer’s
and Dementia. 2021: 1-10. 3 Cummings J et al. Criteria for
Psychosis in Major and Mild Neurocognitive Disorders: International
Psychogeriatric Associations (IPA) Consensus Clinical and Research
Definition. Am J of Geriatric Psychiatry. 2020; 28(12): 1256-1269.
4 Ballard C et al. A prospective study of psychotic symptoms in
dementia sufferers: psychosis in dementia. Int Psychogeriatr. 1997;
9(1): 57-64. 5 Scarmeas N et al. Delusions and hallucinations are
associated with worse outcome in Alzheimer Disease. Arch Neurol.
2005; 62(10): 1601-1608. 6 Peters ME et al. Neuropsychiatric
symptoms as predictors of progression to severe Alzheimer’s
dementia and death: the Cache County Dementia Progression study. Am
J Psychiatry. 2015; 172(5): 460-465.
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Media Contact: Acadia Pharmaceuticals Inc. Deb Kazenelson (818)
395-3043 media@acadia-pharm.com
Investor Contact: Acadia Pharmaceuticals Inc. Al Kildani (858)
261-2872 ir@acadia-pharm.com
Acadia Pharmaceuticals Inc. Jessica Tieszen (858) 261-2950
ir@acadia-pharm.com
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