Repeated Subcutaneous Administration of ABvac40 in Mild to Moderate Alzheimer's Disease Patients

NCT03113812 | Completed Phase 1 DMC

• 1 other identifier: AB1203
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

This first time study in humans was designed to assess tolerability and safety of repeated subcutaneous injections of ABvac40, an active immunization against the C-terminal end of Abeta1-40.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• number of participants with adverse events

  frequency of adverse events; overall and grouped as neurological, psychiatric and cardiovascular.

  up to week 16

Study Arms (2)

ABvac40

EXPERIMENTAL

Drug: ABvac40

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ABvac40 DRUG

ABvac40

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis suggesting Alzheimer's disease (AD) based on the criteria of the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA).
• The results of the patient's MRI brain scan had to be concordant with the diagnosis of AD according to the following criteria: Scheltens scale, and quantitative measurement of white matter and past hemorrhages.
• Severity of Alzheimer's disease (AD) assessed as mild or moderate using the Mini Mental State Examination (MMSE) scale. Mild or moderate AD was confirmed if the MMSE score varied between 15 and 26.
• The Hachinski ischemic scale was used to distinguish AD from multi-infarct dementia. A score of ≤4 suggested AD.
• Score on the Clinical Dementia Rating Scale (CDR) of 0.5 or 1.0.
• Be receiving a stable dose of treatment for AD for three months before the selection visit, and expecting to continue treatment for the duration of the study (if appropriate).
• Stable treatment for other illnesses may be administered 30 days prior to V0 (selection).
• Males or females from 50 to 85 years of age, inclusive (at the time of signing informed consent).
• The patient (or a close relative or legal representative) should read the patient information sheet, agreed to participate in the clinical trial and signed Inform consent (IC) (the patient and a close relative or legal representative).
• Presence of a stable caregiver willing to attend patient visits during the study.
• Sufficient visual and auditory capacity to undertake the neuropsychological tests.
• Positive assessment of the candidate by the investigator for complying with the requirements and procedures of the study.

You may not qualify if:

• Pregnant women or women of child-bearing age.
• Patients whose general state of health was such that it did not allow completion of the trial or that made taking part in the trial difficult, as judged by the investigator.
• Participation in another clinical trial in the 3 months prior to visit 0 or during the 12 months prior to the selection visit in the case of patients who had participated in trials where the study drug was aimed at modifying the progression of AD.
• Known allergy to the vaccine components or history of anaphylaxis, severe allergic reaction or history of hypersensitivity to any of the components of the formulation.
• Allergy to fish or shellfish.
• Absolute (having a pacemaker or implantable defibrillator) or relative (bare metal stent or stent implanted in the last 6 months) contraindications to MRI examination.
• Surgery (with general anesthetic) during the 3 months prior to admission into the study and/or surgery planned at any point during the study period.
• History or presence of autoimmune disease.
• Presence or history of immunodeficiency (e.g. HIV).
• Recent history of cancer (≤3 years since the last specific treatment). (Exceptions:
• basal-cell carcinoma, intraepithelial cervical neoplasia).
• Active infectious disease (e.g. hepatitis B, C) or history of chronic viral hepatitis or other chronic hepatic disorders.
• Major systemic condition (e.g. chronic renal failure, chronic hepatopathy, uncontrolled diabetes, uncontrolled congestive heart failure, other deficiencies).
• History of asthma or reactive airway disease presenting as bronchospasm in the last 6 months or currently on a regular anti-asthmatic drug treatment.
• Poorly controlled diseases like poorly controlled hypertension (systolic arterial tension \>160 mmHg or diastolic arterial tension \>100 mmHg, as an average of 3 measurements) or poorly controlled diabetes according to the investigator's opinion (HbA1c \> 12.0).

Sponsors & Collaborators

• Araclon Biotech S.L.: lead

Related Publications (1)

• Lacosta AM, Pascual-Lucas M, Pesini P, Casabona D, Perez-Grijalba V, Marcos-Campos I, Sarasa L, Canudas J, Badi H, Monleon I, San-Jose I, Munuera J, Rodriguez-Gomez O, Abdelnour C, Lafuente A, Buendia M, Boada M, Tarraga L, Ruiz A, Sarasa M. Safety, tolerability and immunogenicity of an active anti-Abeta40 vaccine (ABvac40) in patients with Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase I trial. Alzheimers Res Ther. 2018 Jan 29;10(1):12. doi: 10.1186/s13195-018-0340-8.

  PMID: 29378651 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: April 4, 2017
• First Posted: April 14, 2017
• Study Start: January 1, 2014
• Primary Completion: July 30, 2015
• Study Completion: July 30, 2015
• Last Updated: April 14, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share