Active — Not RecruitingPhase 1

PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD)

United States144 participantsStarted 2024-12-13

Plain-language summary

This Phase 1b study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of multiple IV infusions of PMN310 in patients with early Alzheimer's disease.

Who can participate

Age range50 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

✓. Patient and caregiver provide written informed consent.
✓. Ambulatory male or female ≥ 50 years of age with adequate visual and auditory abilities to perform the cognitive and functional assessments in the opinion of the Investigator.
✓. Meets all of the following clinical criteria for mild cognitive impairment (MCI) due to AD or mild AD dementia at Screening:
✓. National Institute on Aging-Alzheimer's Association criteria for MCI due to AD or mild AD dementia (Stage 3 and 4)
✓. Global Clinical Dementia Rating (CDR) of 0.5 1.0 and memory box score ≥ 0.5 at Screening and Baseline
✓. Objective impairment in episodic memory as indicated by at least 1 standard deviation (SD) below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory (subscale) II
✓. MMSE score between ≥ 20 and 28 inclusive at Screening, and
✓. Either a positive amyloid PET scan within 6 months of Screening consistent with AD, or a positive amyloid PET during Screening.

Exclusion criteria

✕. Living in a continuous care or long-term care nursing facility. Patients in outpatient living at home or in an assisted living facility are eligible for the study.
✕. Medical or neurological condition (other than AD; i.e., Parkinson's disease, Huntington's disease, frontal temporal dementia, dementia with Lewy bodies) judged to be contributing to the patient's cognitive impairment.
✕. Laboratory and electrocardiogram (ECG) abnormalities:
✕. QT (QTcF) interval \> 450 msec (males) or \> 470 msec (females) during Screening
✕. Alanine aminotransferase ≥ 2 × upper limit of normal (ULN); aspartate aminotransferase ≥ 2 × ULN; total bilirubin ≥1.5 × ULN during Screening
✕. Creatinine clearance \< 30mL/min during Screening.
✕. In the opinion of the Investigator, any clinically significant current or relevant history of physical or psychiatric illness (including suicidal risk, ideation, behavior, or suicide attempts), any medical disorder that may require treatment or make the patient unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
✕. Clinically significant recurrent disease or unstable disease that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments, such as (but not limited to) the following:

What they're measuring

Safety and tolerability of PMN310 following repeat intravenous infusions of PMN310

Timeframe: Up to Day 365

Biomarker response to PMN310 following repeat intravenous infusions of PMN310

Timeframe: Up to Day 365

Safety and tolerability of PMN310 following repeat intravenous infusions of PMN310

Timeframe: Up to Day 365

Biomarker response to PMN310 following repeat intravenous infusions of PMN310

Timeframe: Up to Day 365

Trial details

NCT IDNCT06750432

SponsorProMis Neurosciences, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Alzheimer Disease, Early Onset trials

Who can participate

Age range50 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

✓. Patient and caregiver provide written informed consent.
✓. Ambulatory male or female ≥ 50 years of age with adequate visual and auditory abilities to perform the cognitive and functional assessments in the opinion of the Investigator.
✓. Meets all of the following clinical criteria for mild cognitive impairment (MCI) due to AD or mild AD dementia at Screening:
✓. National Institute on Aging-Alzheimer's Association criteria for MCI due to AD or mild AD dementia (Stage 3 and 4)
✓. Global Clinical Dementia Rating (CDR) of 0.5 1.0 and memory box score ≥ 0.5 at Screening and Baseline
✓. Objective impairment in episodic memory as indicated by at least 1 standard deviation (SD) below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory (subscale) II
✓. MMSE score between ≥ 20 and 28 inclusive at Screening, and
✓. Either a positive amyloid PET scan within 6 months of Screening consistent with AD, or a positive amyloid PET during Screening.

Exclusion criteria

✕. Living in a continuous care or long-term care nursing facility. Patients in outpatient living at home or in an assisted living facility are eligible for the study.
✕. Medical or neurological condition (other than AD; i.e., Parkinson's disease, Huntington's disease, frontal temporal dementia, dementia with Lewy bodies) judged to be contributing to the patient's cognitive impairment.
✕. Laboratory and electrocardiogram (ECG) abnormalities:
✕. QT (QTcF) interval \> 450 msec (males) or \> 470 msec (females) during Screening
✕. Alanine aminotransferase ≥ 2 × upper limit of normal (ULN); aspartate aminotransferase ≥ 2 × ULN; total bilirubin ≥1.5 × ULN during Screening
✕. Creatinine clearance \< 30mL/min during Screening.
✕. In the opinion of the Investigator, any clinically significant current or relevant history of physical or psychiatric illness (including suicidal risk, ideation, behavior, or suicide attempts), any medical disorder that may require treatment or make the patient unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
✕. Clinically significant recurrent disease or unstable disease that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments, such as (but not limited to) the following:

What they're measuring

Safety and tolerability of PMN310 following repeat intravenous infusions of PMN310

Timeframe: Up to Day 365

Biomarker response to PMN310 following repeat intravenous infusions of PMN310

Timeframe: Up to Day 365

Safety and tolerability of PMN310 following repeat intravenous infusions of PMN310

Timeframe: Up to Day 365

Biomarker response to PMN310 following repeat intravenous infusions of PMN310

Timeframe: Up to Day 365