DOPAD-3

A Phase 3 study of rotigotine in combination with rivastigmine in mild to moderate Alzheimer's disease

Conditions

Mild Alzheimer's dementia

Moderate Alzheimer’s dementia

Sponsor

I.R.C.C.S. Fondazione Santa Lucia

Clinical Trial

Phase III

Status

Currently recruiting

Drug

Rotigotine

Countries

Germany, Italy

Information about the drug that will be tested in the study

Administration

Once-daily transdermal patch

Is the drug already on the market for another medical condition?

Yes – approved to treat Parkinson’s disease and restless legs syndrome in Europe and US

Will all participants receive the same drug?

Participants will be selected by chance to receive one of the following options:

Rotigotine (4 mg/24 hours)
Placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).

Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the efficacy of rotigotine in combination with rivastigmine on frontal lobe cognitive functions as compared to rivastigmine in combination with placebo in people with mild to moderate Alzheimer's disease.

How long will the treatment last?

24 weeks

What your involvement will entail?

During the study, participants will be asked to complete some tests that will assess their cognition, functional performance, and activities of daily living (FAB, MoCa, CDR, ADAS-Cog14, ADCS-ADL, MMSE)
To complete another test to evaluate the apathy and motivation (AMI)
To undergo brain scans
To complete some laboratory tests (blood) and neurological examination including an electroencephalogram (EEG), which is a test that measures electrical activity in the brain.

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

Be between 50 and 85 years old
Have results of brain scans consistent with the clinical diagnosis of Alzheimer's disease and excluding other potential causes of dementia
Have a score of 0.5 or 1 in the Clinical Dementia Rating-Global Score (CDR) and between 18 and 26 in the MMSE score. This would suggest that the person has an impairment in their memory that is at a mild to moderate stage
Have a score below 14 in the FAB test, showing evidence of frontal lobe dysfunctions
Have a study partner who has a sufficient contact with the participant and is willing to participate in study procedures throughout the study duration
If the person is taking pharmacological treatment for any other chronic condition, the dosing regimen must be on a stable dost for at least one month.

Who cannot participate in the study?

People cannot take part in the study if they have or have experienced:

A disease or medical condition that may interfere with the study assessments (i.e. psychosis, chronic liver disease, respiratory insufficiency, renal insufficiency, heart disease, hypertension, uncontrolled diabetes)
Other type of dementia (i.e. dementia with Lewy bodies, frontotemporal dementia) or other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis)
Women who are fertile and of childbearing potential
Suspected or known drug or alcohol abuse
Suicidal ideation and behaviour.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.