Safety, Tolerability, and Pharmacokinetics Study of NDX-1017

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

This Phase 1 randomized, placebo-controlled, double-blinded, first-in-human study will evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of NDX-1017 in healthy young and elderly subjects, and elderly subjects with amnestic mild cognitive impairment (MCI), Alzheimer's disease (mild, mild-to-moderate, or moderate), or mixed dementia with Alzheimer's and vascular components (mild, mild-to-moderate, or moderate).

Key facts

Study ID

NCT03298672

Run by

LeonaBio

People needed

88

Starts

2017-10-09

Expected to finish

2019-09-05

Last updated by the study team

2019-09-10

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Generally in good health
• Body mass index (BMI) of ≥ 18.0 and ≤ 30.0 kg/m2 at Screening, with minimum weight of 60 kg. (No BMI upper limit for mild AD and amnestic MCI subjects)
• Male subjects and their partners must be willing to comply with the contraceptive requirements of the study. Only female subjects of non-childbearing potential are eligible for participation.
• [Young subjects] Male subjects must be aged 18 to 45 years (inclusive) at the time of Screening.
• [Healthy elder subjects only] Male and female subjects must be aged 60 to 85 years at the time of screening
• [Amnestic MCI and Alzheimer's Subjects] 9. Patients with Alzheimer's disease, with confirmed diagnosis of amnestic mild cognitive impairment, Alzheimer's disease (mild, mild-to-moderate, or moderate), or mixed dementia with Alzheimer's and vascular components (mild, mild-to-moderate, or moderate).
• Either newly diagnosed treatment naïve patients, OR,
• Patients who are currently on standard Alzheimer's Disease treatment may be considered for participation if they are not tolerating treatment and/or they are willing and clinically able to tolerate a discontinuation, 14 days for dose titration + 5x half-lives for washout, or 4 weeks (whichever is longer) prior to randomization. For these patients, the screening window will be allowed for up to 90 days prior to randomization to evaluate discontinuation of symptomatic treatment for Alzheimer's disease.

You may not qualify if…

• Any medical condition that requires chronic medication use.
• History of drug and/or alcohol abuse within 12 months prior to Screening.
• History of having taken another investigational drug within 30 days prior to Admission (Day -1).
• Donation of blood or plasma within 30 days prior to dosing.
• Major surgery within 90 days prior to Admission (Day -1) or anticipated surgery during the study.
• Smokers
• [Healthy elderly subjects] Reported changes in cognition and reported history of declines in everyday life in the last year.

Where it is running

• Biotrial Inc. — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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