Study on the Effects of GV1001 for Patients with Mild to Moderate Alzheimer’s Disease

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What is this study about?

This clinical trial is focused on studying Alzheimer’s Disease, a condition that affects memory and thinking skills. The study is testing a treatment called GV1001, which is given as an injection under the skin. The main goal of the study is to evaluate how well GV1001 works in improving memory and thinking abilities in people with mild to moderate Alzheimer’s Disease, as well as to assess its safety.

Participants in the study will receive either GV1001 at different doses or a placebo. The study will last for 52 weeks, during which participants will have regular check-ups to monitor their health and any changes in their condition. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will undergo various assessments to track changes in their cognitive abilities, which refers to their memory and thinking skills. These assessments will help determine the effectiveness of GV1001 in treating Alzheimer’s Disease. The safety of the treatment will also be closely monitored through regular health checks, including blood tests and other evaluations. The study aims to provide valuable information on the potential benefits and risks of using GV1001 for this condition.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the study medication, GV1001, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

2 medication administration

The study medication, GV1001, is administered as an injection under the skin. The dosage will be either 0.56 mg or 1.12 mg, depending on the group assignment.

Injections are given according to the study schedule, which spans a total of 52 weeks.

3 regular assessments

Throughout the study, participants will undergo regular assessments to monitor cognitive function and overall health. These assessments include tests like the ADAS-cog11, which measures cognitive abilities.

Additional evaluations will include laboratory tests, ECGs, and vital sign measurements to ensure safety.

4 monitoring and follow-up

Participants will be monitored for any changes in their condition or any side effects from the medication. This includes regular visits to the study center for assessments at specified intervals: Week 12, Week 26, Week 38, and Week 52.

The study will also track any adverse events or changes in health status.

5 completion of the study

At the end of the 52-week period, participants will undergo a final assessment to evaluate the effects of the treatment.

The study aims to determine the efficacy and safety of GV1001 in treating mild to moderate Alzheimer’s disease.

Who Can Join the Study?

Participants must be between 55 and 85 years old.
Participants must have a diagnosis of probable Alzheimer’s Disease (AD) based on specific criteria, which includes memory problems that have been getting worse over more than 6 months.
Participants must have mild to moderate dementia, shown by a specific score on a test called the MMSE.
If taking medication for Alzheimer’s Disease (except certain types), the dose must have been stable for at least 12 weeks before starting the study.
If taking over-the-counter supplements for memory, like gingko biloba or omega-3, the dose must not exceed the recommended amount for at least 12 weeks before starting the study.
Participants must be able to visit the study center and complete various tests.
Participants must have a caregiver who can attend all study visits, help with study procedures, and provide information about the participant’s behavior and safety. The caregiver should spend enough time with the participant to notice changes and must be able to understand and speak the language used at the study center.
Male participants must agree to use a reliable method of birth control during the study and for 3 months after the last dose, and must not donate sperm during this time.
Female participants must not be pregnant or breastfeeding. If they can have children, they must use a reliable method of birth control during the study and for 3 months after the last dose, and have negative pregnancy tests before starting the study.
Participants must provide written consent to join the study, either themselves or through a legal representative, along with their caregiver.

Who Cannot Join the Study?

Individuals who do not have a diagnosis of Alzheimer’s Disease cannot participate. Alzheimer’s Disease is a condition that affects memory and thinking skills.
Participants must be within a specific age range, typically adults and older adults.
Both males and females are eligible, but certain health conditions may exclude participation.
Individuals who are considered part of a vulnerable population may not be eligible. Vulnerable populations include groups that may have additional risks or require special protection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
ClinHouse Centrum Medyczne	Zabrze	Poland
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Galen Clinic	Lublin	Poland
Oncopole Claudius Regaud	Toulouse	France
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Novo-Med Zielinski I Wspolnicy Sp. j.	Katowice	Poland
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Fundacio Ace Institut Catala De Neurociencies Aplicades	Barcelona	Spain
Brain Research Center Amsterdam B.V.	Amsterdam	The Netherlands
Centrum Medyczne Neuromed Sp. z o.o.	Bydgoszcz	Poland
Brain Research Center Zwolle B.V.	Zwolle	The Netherlands
Unidade Local De Saude De Matosinhos E.P.E.	Senhora Da Hora	Portugal
Hospital Victoria Eugenia De La Cruz Roja Espanola	Sevilla	Spain
Brain Research Center Den Bosch B.V.	s-Hertogenbosch	The Netherlands
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Centre Hospitalier Lyon Sud	Pierre Benite	France
Neuroprotect Sp. z o.o.	Warsaw	Poland
NZOZ Wrocławskie Centrum Alzheimerowskie	Wroclaw	Poland
Cqpz Dj Cxfk Idun Scvipu	Milan	Italy
Sdsiug Ttuoeojfzbq On	Oulu	Finland
Htrjswkx Vhds dxdlavqy	Barcelona	Spain
Igfdppgm Zvnnwjr Dh Bvhszzisbakmxnofy	Oświęcim	Poland

Trial status

Country	Status	Recruitment Start
Finland	Not recruiting	12.12.2022
France	Not recruiting	12.12.2022
Italy	Not recruiting	12.12.2022
Poland	Not recruiting	12.12.2022
Portugal	Not recruiting	12.12.2022
Spain	Not recruiting	12.12.2022
The Netherlands	Not recruiting	12.12.2022

Trial locations

Investigated drugs:

Tertomotide

GV1001 is a medication being studied for its potential to help people with mild to moderate Alzheimer’s Disease. It is given as an injection under the skin. The main goal of the study is to see if GV1001 can improve thinking and memory skills in people with Alzheimer’s. The study also aims to ensure that GV1001 is safe for the participants to use.

Alzheimer’s Disease – Alzheimer’s Disease is a progressive neurological disorder that leads to memory loss and cognitive decline. It primarily affects older adults and is characterized by the gradual deterioration of brain cells. Symptoms often begin with mild memory lapses and confusion, eventually progressing to more severe memory impairment, disorientation, and difficulty with language and reasoning. As the disease advances, individuals may experience changes in behavior and personality, and they may require assistance with daily activities. The progression of Alzheimer’s Disease varies among individuals, but it typically worsens over time, affecting the ability to perform everyday tasks.

Trial ID:

2024-511610-20-00

Protocol code:

GV1001-AD-CL2-007

NCT ID:

NCT05189210

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of GV1001 for Patients with Mild to Moderate Alzheimer’s Disease

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