Randomised, double-blind, placebo-controlled study to assess safety and efficacy of PRI-002 in patients with MCI or mild dementia due to Alzheimer’s disease (AD)
- Conditions
- Alzheimer's diseaseMedDRA version: 20.0Level: LLTClassification code: 10001896Term: Alzheimer's disease Class: 10029205Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2022-503148-41-00
- Lead Sponsor
- Prinnovation GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 305
Signed and dated written informed consent obtained from the subject and study companion in accordance with applicable regulations, Male or female, aged 55 to 80 years, inclusive, For female subjects: not being of child-bearing potential, Body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive, Diagnosed with MCI due to AD or mild dementia due to AD, according to the NIA-AA criteria, MMSE score of 22 to 30, inclusive, Repeatable battery for the assessment of neuropsychological status - delayed memory index (RBANS-DMI) score =85, CDR global score of 0.5 or 1 with a memory score =0.5, Confirmation of AD diagnosis, by CSF biomarker profile reflecting AD, according to NIA-AA, or existing positive amyloid positron emission tomography (PET) evidence
History or evidence of any other central nervous system (CNS) disorder(s) that could be interpreted as a cause of cognitive impairment or dementia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method