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Tertomotide

This article discusses a phase 2 clinical trial investigating the use of Tertomotide (GV1001) in treating mild to moderate Alzheimer’s disease. The study aims to assess the safety and efficacy of this drug when administered subcutaneously over a 52-week period. The trial is designed as a multicenter, randomized, double-blind, placebo-controlled study, focusing on cognitive improvements and overall patient function.

Table of Contents

What is TERTOMOTIDE (GV1001)?

TERTOMOTIDE, also known by its product code GV1001, is an investigational drug being studied for the treatment of mild to moderate Alzheimer’s disease (AD)[1]. Alzheimer’s disease is a progressive brain disorder that affects memory, thinking skills, and the ability to carry out simple tasks. It is the most common cause of dementia in older adults.

How Does TERTOMOTIDE Work?

While the exact mechanism of action is not fully described in the provided information, TERTOMOTIDE is classified as a protein-based drug[1]. Proteins play crucial roles in the body, and in the case of Alzheimer’s disease, they may help address some of the underlying biological processes involved in the progression of the disease.

Current Research on TERTOMOTIDE

TERTOMOTIDE is currently being studied in a Phase 2 clinical trial for patients with mild to moderate Alzheimer’s disease[1]. This study aims to evaluate both the safety and efficacy of the drug. Here are some key points about the ongoing research:

  • The study is designed as a multicenter, randomized, double-blind, placebo-controlled trial[1].
  • It will last for 52 weeks (about one year)[1].
  • Participants are divided into three groups: two groups receiving different doses of TERTOMOTIDE (0.56 mg and 1.12 mg) and one group receiving a placebo[1].
  • The main goal is to assess how TERTOMOTIDE affects cognition (thinking and memory) in people with mild to moderate Alzheimer’s disease[1].

How is TERTOMOTIDE Administered?

TERTOMOTIDE is administered as a subcutaneous injection[1]. This means the medication is injected just under the skin, typically in areas with fatty tissue such as the abdomen or thigh. The study is testing two different doses: 0.56 mg and 1.12 mg[1].

Who is Eligible for TERTOMOTIDE Treatment?

The current clinical trial has specific eligibility criteria. Some key points include:

  • Participants must be between 55 and 85 years old[1].
  • They must have a diagnosis of probable Alzheimer’s disease[1].
  • Participants should have mild to moderate dementia, as determined by a specific cognitive test (MMSE score between 13 and 24)[1].
  • They must have a caregiver who can accompany them to study visits and provide information about their condition[1].

There are also several exclusion criteria, such as other causes of dementia, certain psychiatric conditions, and specific medical conditions[1].

Potential Benefits of TERTOMOTIDE

The study aims to evaluate several potential benefits of TERTOMOTIDE, including:

  • Improvements in cognitive function[1].
  • Changes in daily living activities[1].
  • Effects on behavioral symptoms associated with Alzheimer’s disease[1].
  • Overall changes in the severity of dementia[1].
  • Improvements in quality of life[1].

It’s important to note that as this is an ongoing study, the actual benefits are yet to be determined.

Safety Considerations

As with any investigational drug, safety is a primary concern. The study is closely monitoring for any adverse events (side effects) that may occur during treatment[1]. This includes regular laboratory tests, ECG (heart) examinations, and monitoring of vital signs. The study is also assessing for any potential risk of suicidal thoughts or behaviors[1].

It’s crucial to understand that as TERTOMOTIDE is still in the research phase, not all potential risks and side effects may be known. Patients considering participation in clinical trials should discuss all potential risks and benefits with their healthcare providers and study investigators.

Aspect Details
Study Type Phase 2 clinical trial
Drug Tertomotide (GV1001)
Condition Mild to moderate Alzheimer’s disease
Duration 52 weeks
Administration Subcutaneous injection
Dosages 0.56 mg and 1.12 mg
Primary Outcome Change in ADAS-Cog11 score at Week 52
Key Eligibility Age 55-85, MMSE score 13-24, probable AD diagnosis
Safety Monitoring Adverse events, lab tests, ECG, vital signs, C-SSRS

FAQ

  • What is Tertomotide (GV1001) and how is it being studied? Tertomotide, also known as GV1001, is a drug being investigated for the treatment of mild to moderate Alzheimer's disease. It's being studied in a 52-week phase 2 clinical trial where it's administered subcutaneously (under the skin) to evaluate its safety and effectiveness.
  • Who can participate in this clinical trial? Participants must be between 55 and 85 years old, diagnosed with probable Alzheimer's disease, have mild to moderate dementia (MMSE score between 13 and 24), and meet other specific criteria. They must also have a caregiver who can accompany them to study visits and provide information about the participant's condition.
  • What are the main goals of this clinical trial? The main objectives are to evaluate the efficacy of GV1001 in improving cognition in patients with mild to moderate Alzheimer's disease, as measured by the ADAS-cog11 scale, and to assess the safety of the drug in these patients.
  • How long does the trial last and what does it involve? The trial lasts for 52 weeks. Participants will be randomly assigned to receive either a low dose of GV1001 (0.56 mg), a high dose of GV1001 (1.12 mg), or a placebo. Throughout the study, various cognitive and functional assessments will be conducted to measure the drug's effects.
  • What are some of the key measurements used in this trial? The trial uses several measurements to assess the drug's effectiveness, including the ADAS-cog11 for cognition, A-IADL-Q for daily living activities, NPI for behavioral symptoms, MMSE for cognitive function, CDR-SB for dementia severity, ADCS-CGIC/CIBIC-Plus for overall change, and QoL-AD for quality of life.

Ongoing Clinical Trials on Tertomotide

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

    Not recruiting

    2 1
    Investigated drugs:
    Finland France Italy The Netherlands Poland Portugal +1

Glossary

  • Tertomotide (GV1001): An investigational drug being studied for the treatment of mild to moderate Alzheimer's disease.
  • ADAS-cog11: Alzheimer's Disease Assessment Scale-Cognitive Subscale, a test used to measure cognitive function in Alzheimer's patients.
  • MMSE: Mini-Mental State Examination, a widely used test of cognitive function.
  • A-IADL-Q: Amsterdam Instrumental Activities of Daily Living Questionnaire, used to assess functional abilities in daily life.
  • NPI: Neuropsychiatric Inventory, a tool to assess behavioral symptoms in dementia patients.
  • CDR-SB: Clinical Dementia Rating Scale-Sum of Boxes, used to measure the severity of dementia.
  • ADCS-CGIC/CIBIC-Plus: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change, used to assess overall change in a patient's condition.
  • QoL-AD: Quality of Life in Alzheimer's Disease, a measure to assess the quality of life in Alzheimer's patients.
  • Subcutaneous: A method of administering medication under the skin.
  • Double-blind: A study design where neither the participants nor the researchers know who is receiving the actual treatment or placebo.
  • Placebo: An inactive substance used as a control in a clinical trial.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-gv1001-for-patients-with-mild-to-moderate-alzheimers-disease/