Neurological

AIMM - Closed

Acipimox in Mitochondrial Myopathy

Study stage: Closed
Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
Funder: MRC- DPFS
Therapeutic area: Neurological
Type of study: CTIMP

Aim: To determine whether Acipimox can be repurposed as a potent stimulator of mitochondrial biogenesis. Participants will be treated with Acipimox or matched placebo to determine what effect treatment has on the Adenosine Triphosphate (ATP) content of the muscle.

Primary outcome:

To establish if ATP content in skeletal muscle is increased, as measured by luminescence assay, in patients with mitochondrial disease and muscle involvement following treatment with Acipimox for 12 weeks.

Population: Adult
Design: RCT Adaptive
Setting: Secondary care
Planned Sample Size: 120

Website: https://www.thelilyfoundation.org.uk/lily-research/uk-trials-research-studies/aimm-acipimox-mitochondrial-myopathy-study/

COBALT - Recruiting

COmBining memantine And cholinesterase inhibitors in Lewy body dementia treatment Trial

Study stage: Recruiting
Sponsor: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Funder: NIHR HTA
Therapeutic area: Neurological
Type of study: CTIMP

Aim:

1) To determine the effectiveness of augmenting AChEI with memantine in patients with DLB.

2) To determine the effectiveness of augmenting AChEI with memantine in patients with PDD.

Primary Outcome:

For each trial, intention to treat analysis will evaluate the effect of AChEI plus memantine versus AChEI alone on ADCS-CGIC score at 26 weeks, adjusting for baseline disease severity (defined by level of cognitive impairment) and country.

Population: Adult
Phase: III
Design: Basket
Setting: Secondary care
Planned Sample Size: 372

Website: https://research.ncl.ac.uk/cobalttrial

Diamond Lewy - Closed

Improving the diagnosis and management of neurodegenerative dementia of Lewy body type in the NHS.

Study stage: Closed
Sponsor: Northumberland Tyne and Wear NHS Foundation Trust
Funder: NIHR Programme Grant
Therapeutic area: Neurological
Type of study: Non-clinical Intervention

Aim:

Determine feasibility of use of the intervention
Assess the impact of the assessment and management toolkit on patient management, health outcomes, and its impact on informants/carers
Provide an exploratory comparison of the cost-effectiveness of the new assessment and management toolkit for LBD with usual care

Population: Adult
Design: Pilot, cluster randomised controlled trial
Setting: Secondary care
Planned Sample Size: 240

Fairpark II - Closed

Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease

Study stage: Closed
Sponsor: Lille University
Funder: European Commission Horizon 2020 Grant
Therapeutic area: Neurological
Type of study: CTIMP

Aim: To demonstrate for the first time in a large phase II, randomised, placebo-controlled trial that conservative iron chelation, with the prototype drug Deferiprone, will slow down the progression of symptoms in Parkinson's disease patients and will not be associated with a clinically negative benefit / risk ratio.

Primary outcome:

The change in the total MDS-UPDRS score between baseline and 36 weeks (i.e. the end of the placebo-controlled phase for analysis of both disease modifying and symptomatic effects).

Population: Adult
Phase: IIb
Design: RCT
Setting: Secondary care
Planned Sample Size: 322

OACS-3 - Recruiting

Obeticholic acid for the Amelioration of Cognitive Symptoms trial - 3

Study stage: Recruiting
Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
Funder: IIT- Intercept Pharmaceuticals
Therapeutic area: Neurological
Type of study: CTIMP

Aim: To assess safety and tolerability of OCA treatment in patients with PD.