CompletedPhase 1

A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease

Australia2 participantsStarted 2024-04-17

Plain-language summary

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1707 in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD for 26 weeks.

Who can participate

Age range55 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
✓. Male or female aged between 55 years and 85 years (inclusive) at the date of signed consent form.
✓. Total body weight of 45\~100 kg (inclusive), with a body mass index (BMI) of 19\~32 kg/m2 (inclusive)at screening or baseline.
✓. The subjects must meet the following clinical criteria for Mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or criteria for mild AD.
✓. The subjects should have a stable caregiver who will help the patients to participate in the whole study process.

Exclusion criteria

✕. Cognitive impairment due to other medical or neurological factors (non-AD).
✕. History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past 1 year.
✕. Any psychiatric diagnosis that may interfere with the subject's cognitive assessment.
✕. Inability to tolerate MRI examination or have contraindications to MRI examination.
✕4.Have had prior treatment with an anti-amyloid immunotherapy within 1 year prior to randomization.

What they're measuring

Adverse events(AEs)

Timeframe: week 26

Baseline in vital signs value

Timeframe: week 26

Physical examination

Timeframe: week 26

Laboratory examination

Timeframe: week 26

Baseline in 12-ECG values

Timeframe: week 26

MRI

Timeframe: week 26

Trial details

NCT IDNCT06114745

SponsorAtridia Pty Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-08

View on ClinicalTrials.gov More Alzheimer's Disease (AD) trials

Who can participate

Age range55 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
✓. Male or female aged between 55 years and 85 years (inclusive) at the date of signed consent form.
✓. Total body weight of 45\~100 kg (inclusive), with a body mass index (BMI) of 19\~32 kg/m2 (inclusive)at screening or baseline.
✓. The subjects must meet the following clinical criteria for Mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or criteria for mild AD.
✓. The subjects should have a stable caregiver who will help the patients to participate in the whole study process.

Exclusion criteria

✕. Cognitive impairment due to other medical or neurological factors (non-AD).
✕. History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past 1 year.
✕. Any psychiatric diagnosis that may interfere with the subject's cognitive assessment.
✕. Inability to tolerate MRI examination or have contraindications to MRI examination.
✕4.Have had prior treatment with an anti-amyloid immunotherapy within 1 year prior to randomization.