Trials Sponsors Conditions Drugs Pricing

Conditions

Moderate Alzheimer's Disease

Keywords

Alzheimer's DiseaseGV1001

Outcome Measures

Primary Outcomes (1)

Alzheimer's Disease Assessment Scale-cognitive (ADAS-cog)
The proportion of participants with any improvement in ADAS-cog compared to the baseline and Week 26
Week 26

Secondary Outcomes (6)

Alzheimer's Disease Assessment Scale-cognitive (ADAS cog)
Week 26
Clinician's Interview-Based Impression of Change (CIBIC)-Plus
Week 26
Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Week 26
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Week 26
Neuropsychiatric Inventory (NPI)
Week 26
+1 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24

Drug: Normal saline

GV1001 0.56 mg

EXPERIMENTAL

GV1001 0.56 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24

Drug: GV1001

GV1001 1.12 mg

EXPERIMENTAL

GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24

Interventions

GV1001Drug

Lyophilized peptide from hTERT

Also known as: Tertomotide

GV1001 0.56 mgGV1001 1.12 mg

Normal salineDrug

0.9% normal saline

Placebo

Eligibility Criteria

Age55 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female participants 55 to 85 years of age, inclusive, at the time of signing the informed consent.
Diagnosis of probable AD based on NINCDS-ADRDA criteria.

Sponsors & Collaborators

GemVax & Kael
Industrylead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

GV1001 peptideSaline Solution

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic Solutions

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 22, 2019

Study Start

September 1, 2019

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

Any other cause of dementia shown by MRI/CT findings and neurological examination within 12 months of randomization.
Possible, probable, or definite vascular dementia according to the National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences (NINDS-AIREN) criteria.
Evidence of significant abnormality that would suggest another potential etiology for dementia (eg, evidence of cerebral contusion, encephalomalacia, aneurysm, vascular malformation, \>5 microhemorrhages, macrohemorrhage, single infarct \>1cm3).
Other central nervous system diseases that may cause cognitive impairment (eg, cerebrovascular disease including cerebrovascular dementia, Parkinsonism, Huntington's disease, subdural hematoma, normal pressure hydrocephalus, brain tumor, Creutzfeldt-Jakob disease).
Concurrent or history of clinically significant psychiatric conditions (eg. Schizophrenia or bipolar affective disorder) that in the Investigator's opinion prevents the participant from participating, or is likely to confound interpretation of drug effect or affect cognitive assessments.
Vitamin B12, folic acid, syphilis serology, and thyroid stimulating hormone (TSH) results that are thought to contribute to the severity of dementia or cause dementia. Participants may be enrolled if in the Investigator's medical judgment the abnormal laboratory values are not the cause of the cognitive symptoms.
History of known or suspected seizures including febrile seizures (excluding self-limited childhood febrile seizures), a history of significant head trauma with loss of consciousness or recent unconsciousness that is not explained.
Acute or unstable cardiovascular disease, active peptic ulcer, uncontrolled hypertension, uncontrolled diabetes or insulin dependent patients or any medical condition that may interfere with the completion of the clinical study.
Known allergies, hypersensitivity, or intolerance to GV1001 or similar products or excipients.
History of alcohol, substance abuse or dependence as per DSM-V criteria (except nicotine dependence) within the last 2 years.
Concurrent malignancies or invasive cancers diagnosed within the past 5 years except for non-metastatic basal cell carcinoma or squamous cell carcinoma of skin, in situ carcinoma of the uterine cervix or non-metastatic prostate cancer
Sexually-active WOCBP or man capable of fathering a child who do not consent to using medicinally acceptable contraception (such as surgical sterilization, intrauterine contraceptive device, condom or diaphragm, an injectable or inserted contraceptive) during the study and for 3 months after the last dose of study treatment.
Pregnant, breast feeding, or planning a pregnancy or fathering a child while enrolled in the study or for 3 months after the las dose of study treatment.
Use of anxiolytics, narcotics, or sleep aids in a manner that would interfere with cognitive testing, in the opinion of the Investigator. Atypical antipsychotics may be used at the discretion of the Investigator. Tricyclic antidepressants and monoamine oxidase (MAO) inhibitors are prohibited.
Previous treatment with GV1001.
+7 more criteria

Study Stopped

GV1001 Subcutaneous(SC) for the Treatment of Moderate Alzheimer's Disease (AD)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

Placebo

GV1001 0.56 mg

GV1001 1.12 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

Placebo

GV1001 0.56 mg

GV1001 1.12 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record