Clinical Trials List
2024-01-25 - 2029-01-31
Phase III
Recruiting7
ICD-10G30.0
Alzheimer's disease with early onset
ICD-10G30.1
Alzheimer's disease with late onset
ICD-10G30.8
Other Alzheimer's disease
ICD-10G30.9
Alzheimer's disease, unspecified
ICD-9331.0
Alzheimer's disease
A 52-Week, Open-Label Extension Study of ACP-204 in Adults with Alzheimer’s Disease Psychosis
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
ACAIDA
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 張維紘 無
- Wei-Pin Hong 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tzung-Jeng Hwang 無
- 謝明憲 無
- 楊焯翔 無
- Chen-Chung Liu 無
- CHIH-MIN LIU Division of Psychiatry
- 林亦廷 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yu Ao 無
- Yu-Wan Yang 無
- Ming-Kuei Lu 無
- Kuan-Fei Chen 無
- 張芳慈 無
- Hui-Chun Huang 無
- 林欽揚 無
- Hung-Yu Huang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
antecedent ACP-204-006 study
2. The subject may benefit from long-term therapy with
open-label ACP-204 treatment in the judgment of the
Investigator
3. Subject has completed Visit 6 (EOT) of the antecedent
ACP-204-006 study and did not have an early
discontinuation from the antecedent study
4. Has a designated study partner/caregiver (e.g., family
member, social worker, case worker or nurse) who meets
the following requirements:
a. In the Investigator’s opinion, is in contact with the
subject frequently enough to accurately report on
the subject’s symptoms and whether or not the
subject is taking the study drug
b. Is fluent in the local language in which study
assessments will be administered
c. Agrees to participate in study assessments and
provides written consent to participate in the study
5. Can complete all study visits with a study
partner/caregiver
Exclusion Criteria
inappropriate for the study for any reason
2. Is in hospice and receiving end-of-life palliative care, or
has become bedridden
3. Has any of the following ECG results at Baseline (EOT
visit of the antecedent study):
a. If the subject is not on citalopram, escitalopram, or
venlafaxine:
i. QTcF >450 ms, if QRS duration <120 ms
ii. QTcF >470 ms, if QRS duration ≥120 ms
b. If the subject is on citalopram, escitalopram, or
venlafaxine:
i. QTcF >425 ms, if QRS duration <120 ms
ii. QTcF >450 ms, if QRS duration ≥120 ms
4. Has a heart rate <50 beats per minute, as measured by vital
signs at Baseline (EOT visit of the antecedent study). If
bradycardia is secondary to iatrogenic or treatable causes
and these causes are addressed, a heart rate assessment can
be repeated.
5. Has symptomatic orthostatic hypotension including
symptoms such as postural dizziness or pre-syncope, as
measured by UKU orthostatic dizziness severity greater
than zero, or history of falls associated with orthostatic
hypotension, at Baseline (EOT visit of the antecedent
study)
The Estimated Number of Participants
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Taiwan
24 participants
-
Global
752 participants