Evaluation of NBI-1117567 in Participants With Mild to Moderate Alzheimer's Disease (AD) Taking a Background Acetylcholinesterase Inhibitor
A Phase 2a, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of NBI-1117567 in Participants With Mild to Moderate Alzheimer's Disease on Stable Treatment With an Acetylcholinesterase Inhibitor
This study is designed to evaluate the efficacy on improving cognitive performance as well as the safety, tolerability, and pharmacokinetics (PK) of NBI-1117567 administered once daily (QD) in adults with mild to moderate AD who are receiving stable treatment with an acetylcholinesterase inhibitor.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前:Neurocrine Medical Information Call Center
- 電話番号:1-877-641-3461
- メール:medinfo@neurocrine.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Key Inclusion Criteria:
- Participant has a primary diagnosis of mild to moderate AD prior to screening.
- Participant is receiving a well-tolerated treatment with an acetylcholinesterase inhibitor (donepezil, galantamine, or rivastigmine) at a stable dose for at least 3 months prior to the Screening Visit and is required to continue the same treatment at the same dose level throughout the study.
- Negative pregnancy test at screening and Day 1 for participants of childbearing potential.
- Participant is willing and able to comply with all study procedures and restrictions in the opinion of the investigator. Participant can follow instructions and understand and perform all study procedures, including cognitive assessments in the opinion of the investigator.
Key Exclusion Criteria:
- Pregnant (that is, positive pregnancy test at screening, or baseline [Day 1]) or lactating, or plans to become pregnant during the study.
- Participant has other medical or neurological condition or prior clinical findings indicative of alternate or additional causes of cognitive impairment, including but not limited to vascular dementia, multi-infarct dementia, normal pressure hydrocephalus, Parkinson's disease, dementia with Lewy bodies, frontotemporal dementia, multiple sclerosis, amyotrophic lateral sclerosis, hypoxic cerebral damage, encephalitis, central nervous system (CNS) infection, chronic traumatic encephalopathy, and history of head injury with loss of consciousness.
- Participant has an unstable medical condition within the 3 months prior to screening or clinically relevant medical condition interfering with the study as judged by the investigator, as determined from the medical history review and the physical examinations obtained during screening.
- Participant has any primary psychiatric condition or severe psychiatric symptom that in the opinion of the investigator may interfere with the participant's ability to participate in the study or impact the interpretation of study results.
- Participant is undergoing psychological therapy interventions for cognition in AD. Participants undergoing cognitive behavioral therapy for conditions other than AD must be stable for 3 months prior to Day 1 and during the study.
- Participant has previously participated in an interventional clinical study within the preceding 180 days, or 5 half-lives of the experimental treatment, whichever is longer.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:NBI-1117567 Low Dose
Participants will receive the titration dose of NBI-1117567 followed by the target dose (low dose) for 10 weeks. |
NBI-1117567 will be administered per schedule specified in the arm description. |
|
実験的:NBI-1117567 High Dose
Participants will receive the titration dose of NBI-1117567 followed by the target dose (high dose) for 10 weeks. |
NBI-1117567 will be administered per schedule specified in the arm description. |
|
プラセボコンパレーター:Placebo
Participants will receive placebo for 12 weeks. |
Placebo matching to NBI-1117567 will be administered per schedule specified in the arm description. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change From Baseline in Neuropsychological Test Battery (NTB) Composite Score at Day 85
時間枠:Baseline, Day 85
|
Baseline, Day 85
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale, 13 Item Version (ADAS-Cog13) Score at Day 85
時間枠:Baseline, Day 85
|
Baseline, Day 85
|
|
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at Day 85
時間枠:Baseline, Day 85
|
Baseline, Day 85
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Clinical Development Lead、Neurocrine Biosciences
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。