跳至主要内容
临床试验/NCT05771428
NCT05771428已完成2 期

A Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-552 in Participants With Mild Alzheimer's Disease

AbbVie64 个研究点 分布在 4 个国家目标入组 240 人开始时间: 2023年6月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
240
试验地点
64
主要终点
Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) Score at Week 12

研究概览

简要总结

Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. This study will assess how safe and effective ABBV-552 is in treating symptoms of early AD. Adverse events, change in disease activity, how ABBV-552 moves through body of participants and the body response to ABBV-552 will be assessed.

ABBV-552 is an investigational drug being developed for the treatment of Alzheimer's disease (AD). Study doctors put the participants in 1 of 4 groups (3 active dose groups and a placebo group), called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Approximately 240 participants aged 50-90 years with mild AD will be enrolled in approximately 60 sites across the world.

Participants will receive oral ABBV-552 or placebo capsules once daily for 12 weeks and followed for 30 days after the last dose of study drug.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of probable Alzheimer's disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) (2011) criteria.
  • Mini-Mental State Examination (MMSE) score of 20 to 26, a Clinical Dementia Rating (CDR) global score of 0.5 or 1.0, with a CDR memory score of 0.5 or higher, and at least 1 CDR functional domain (community affairs, home and hobbies, or personal care) score of 0.5 or higher at Screening Visit 1.

排除标准

  • - Clinically significant and/or unstable medical conditions or any other reason that the investigator determines would interfere with participation in this study (e.g., unlikely to adhere to the study or procedures, keep appointments, or is planning to relocate during the study) or would make the participant an unsuitable candidate to receive ABBV-552.

研究组 & 干预措施

ABBV-552: 1 mg

Experimental

Participants will receive 1 mg of ABBV-552 once daily (QD) for 12 weeks.

干预措施: ABBV-552 (Drug)

ABBV-552: 5 mg

Experimental

Participants will receive 5 mg of ABBV-552 QD for 12 weeks.

干预措施: ABBV-552 (Drug)

ABBV-552: 15 mg

Experimental

Participants will receive 5 mg of ABBV-552 QD for 12 weeks.

干预措施: ABBV-552 (Drug)

Placebo

Placebo Comparator

Participants will receive placebo for ABBV-552 QD for 12 weeks.

干预措施: Placebo for ABBV-552 (Drug)

结局指标

主要结局

Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) Score at Week 12

时间窗: Week 12

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in mild cognitive impairment (MCI) patients. The Total Score of the ADAS-Cog-14 ranges from 0 to 90, with a higher score representing greater impairment.

次要结局

未报告次要终点

研究者

发起方
AbbVie
申办方类型
Industry
责任方
Sponsor

研究点 (64)

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