Идёт набор NCT07328451

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease

Фаза I С лечением Alzheimer Disease, Early Onset

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: DNL628, Placebo.
Кому может быть актуально: Состояния в реестре: Alzheimer Disease, Early Onset. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Нидерланды, Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease

Обзор

This is a Phase 1b, multicenter, randomized, placebo-controlled, double-blind, multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL628 in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment, or mild AD with biomarker evidence of amyloid positivity. Note: In the Netherlands, this study includes an open-label extension.

Вмешательства

Препарат DNL628
Multiple ascending doses
Препарат Placebo
Multiple ascending doses

Первичные конечные точки

Incidence and severity of treatment-emergent adverse events (TEAEs) throughout the double-blind period [Срок оценки: 37 weeks]

Вторичные конечные точки (8)

PK parameter: Maximum concentration (Cmax) of DNL628 in plasma [Срок оценки: 37 weeks]
PK Parameter: Time to reach maximum concentration (tmax) of DNL628 in plasma [Срок оценки: 37 weeks]
PK Parameter: Minimum concentration (Cmin) of DNL628 in plasma [Срок оценки: 37 weeks]
PK Parameter: Area under the concentration-time curve (AUC) from time zero to time of last measurable concentration (AUClast) of DNL628 in plasma [Срок оценки: 37 weeks]
PK Parameter: AUC from time 0 to the end of the dosing interval (AUCτ) of DNL628 in plasma [Срок оценки: 37 weeks]
PK Parameter: terminal elimination half-life (t1/2) of DNL628 in plasma [Срок оценки: 37 weeks]
PK Parameter: Accumulation ratio of DNL628 in plasma [Срок оценки: 37 weeks]
Change from baseline in total tau and ptau181 as measured in CSF [Срок оценки: 25 weeks]

Критерии участия

Критерии включения

BMI of ≥18 to < 32 kg/m2 and body weight of ≥45 kg
Have a diagnosis of probable AD dementia based on NIA AA 2011 criteria, including amnestic or nonamnestic presentation at screening
Have supportive evidence of AD pathology via historical records or laboratory testing at screening for amyloid positivity
Have AD severity defined as the following at screening:

A Clinical Dementia Rating global score of 0.5 or 1
A Mini-Mental State Examination score of 20 to 30 (inclusive)

Критерии исключения

Have clinically significant neurological or cognitive disorders affecting the CNS other than AD, as determined by the investigator
Have clinically significant psychiatric conditions
Have any history of unstable or poorly controlled endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, hematological, or other significant medical condition that, in the opinion of the investigator, may interfere with the completion or interpretation of study assessment
Have had a malignancy within 5 years before screening, except fully resected basal cell carcinoma or other malignancies (such as prostate cancer) at low risk of recurrence, depending on investigator and medical monitor agreement
Have had previous anti amyloid or anti tau immunotherapy (including active immunization)

Note: ADAD participants who have participated in previous passive anti-amyloid immunotherapy > 6 months previously will be allowed, contingent on investigator and Sponsor agreement
Have had previous exposure to gene therapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет