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Clinical Trials List

Protocol NumberACP-204-008
Active

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    ACAIDA

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Ming-Chyi Pai

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuan-Han Yang Division of Psychiatry

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator YI-TING LIN

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 李介元 Division of Psychiatry

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chung-Hsiang Liu

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuan-Han Yang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Alzheimer’s Disease Psychosis

Objectives

To evaluate the safety and tolerability of long-term ACP-204 treatment in subjects with ADP

Test Drug

tablets

Active Ingredient

ACP-204

Dosage Form

130

Dosage

30 or 60 mg

Endpoints

Treatment-emergent adverse events (TEAEs)

Inclution Criteria

1. The subject satisfied all eligibility criteria at entry into the
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

1. Is judged by the Investigator or the Medical Monitor to be
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

  • Taiwan

    24 participants

  • Global

    752 participants