The GRADUATE I Study
The GRADUATE study is a Phase III Placebo-controlled clinical trial investigating the efficacy and safety of an investigational medication (Gantenerumab) in patients with early (prodromal to mild) Alzheimer’s disease. This investigational medication has already had some testing in humans for safety and effectiveness and is now being tested in a larger group of people to determine if the drug reduces the level of amyloid beta in the brain. This is important because there is evidence to suggest that plaques of amyloid beta in the brain prevent cells in the brain from functioning correctly.
Participants in the GRADUATE study are involved for 3 years not including an optional 2 year open label extension study. Over the length of the study participants receive study medication via injection and monitoring of health and Alzheimer’s disease through a series of regular assessments including blood tests, heart checks, brain imaging and questionnaires.
The Tauriel Study
The Tauriel study is a Phase II Placebo-controlled clinical trial. This study is looking at the safety and efficacy of an investigational medication (MTAU9937A) in patients with early (prodromal to mild) Alzheimer’s disease. This investigational medication looks to bind Tau protein in order to stop or slow tau toxicity and pathology in the brain. Intracellular Tau aggregates are a known pathological finding in Alzheimers disease patients and distribution in the brain correlates with decline in cognitive domains related to the affected brain areas.
Participants in the TAURIEL study are involved in the study for approximately 22 months not including an optional open label extension period for a further 22 months. Over the length of the study participants receive study medication via infusion and monitoring of health and Alzheimer’s disease through a series of regular assessments including blood tests, heart checks, brain imaging and questionnaires.
The Engage Study
The ENGAGE study investigated whether Aducanumab has the potential to be a safe and helpful treatment that slows down disease progression in people with early Alzheimer’s disease. Aducanumab is a drug that has already had some limited testing in humans for safety and effectiveness. There is a substance called amyloid beta (which is a protein) found at high levels in the brains of people with Alzheimer’s disease which is believed to be one of the key features of the progression of the disease. Aducanumab binds amyloid beta and removes existing deposits and stops new deposits from forming. The ENGAGE study consisted of two treatment phases – an initial 18 month treatment period which has a placebo group and an optional 2- year long term extension phase of the study.
Participants in THE ENGAGE study were:
- 50-85 years of age
- In good health (apart from early Alzheimer’s disease)
- Had a study partner who, for the duration of the study, is able to provide accurate information on the participant’s cognitive and functional abilities, and attend at least nine specific clinic visits over the duration of the study.
This trial was discontinued by the Sponsor.
The Early Study
The EARLY clinical trial researched the safety and effectiveness of an investigational medicine that may have helped to delay memory loss associated with Alzheimer’s disease. The investigational medicine developed by Janssen Research and Development was designed to prevent the production of amyloid beta fragments in the brain. Amyloid beta (which is a protein) is found at high levels in the brains of people with Alzheimer’s disease and is believed to be one of the key features of the progression of the disease. This investigational medicine aimed to reduce the formation of these amyloid beta fragments with the goal of slowing down or preventing the cognitive and functional decline associated with Alzheimer’s disease.
This trial was discontinued by the Sponsor.
The TOMMORROW Study (301 & 303)
The TOMMORROW study is a research study seeking to learn more about the earliest stages of Alzheimer’s disease. It seeks to understand the genetic risk factors of developing Mild Cognitive Impairment (MCI) due to Alzheimer’s disease using a genetic blood test. This study will evaluate whether a new investigational test involving two specific genes (APOE gene and the TOMM40 gene) that have been previously shown to increase the risk of developing Alzheimer’s disease, can predict a person’s risk for developing mild cognitive impairment in the next 5 years. The outcomes of this study are still pending.
A second goal was to explore whether an investigational medication will delay the first symptoms of MCI due to AD in people who are cognitively normal. This study was a global phase 3 trial that recruited more than 5,000 healthy senior participants in approximately 50 study centres worldwide. The clinical trial of this investigational medication was discontinued by the Sponsor.
The HAPPy Pilot Project
The Headache Prevention Project (HAPPy) was a study led by the George Institute for Global Health investigated the efficacy of low-dose blood pressure lowering and Cholesterol-lowering treatments in the prevention of migraine.
The trial period for this study has been completed and results are pending.