PK051-201
Research type
Research Study
Full title
A Phase 2a, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PK-051 (Combination of Fluphenazine and Trimipramine) in Patients with Mild Cognitive Impairment
IRAS ID
1006395
Contact name
Kattia Lonsdale
Contact email
Sponsor organisation
PharmaKure Ltd
Research summary
This study will assess how patients living with mild cognitive (thinking) impairment (MCI) respond to taking an investigational medicine PK-051. MCI is the stage between the expected decline in memory and thinking that happens with age and the more serious decline of dementia. Some people with MCI, have a build-up of an abnormal protein, known as amyloid, in their brains. This build-up may lead to further impairment in memory or thinking, and lead to a clinical diagnosis of Alzheimer’s Disease.
PK-051 is an investigational study drug which is being studied in people who have Mild Cognitive (thinking) impairment (MCI). PK-051 is a combination of two, existing licensed drugs, Fluphenazine and Trimipramine. Fluphenazine is a drug used to treat Schizophrenia, and psychotic symptoms such as hallucinations and delusions. Trimipramine is a medication for the treatment of depression and the combination of these two drugs appears . PK-051 appears to breakdown amyloid in the blood and may well stop further buildupbuild-up of amyloid in the brain potentially slowing down the progression of Alzheimer’s Disease. This research may help the Sponsor develop a treatment for Alzheimer’s Disease.
REC name
North of Scotland Research Ethics Committee 1
REC reference
23/NS/0122
Date of REC Opinion
8 Dec 2023
REC opinion
Further Information Favourable Opinion