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Encapsulated Cell Biodelivery of Nerve Growth Factor to Alzheimer´s Disease Patients (NsG0202)

Primary Purpose

Alzheimer's Disease

Status

Unknown status

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

Nerve Growth Factor

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 50-80 years
All patients must fulfil the NINDNDS-ARDRA criteria of Alzheimer's disease.
The subject must have a score between 15-24 inclusive, on the mini-mental state examination (MMSE).
The subject must have a caregiver who is able and committed to assist the subject to comply with the trial protocol, and who is willing to provide the information required at assessment interviews.
Informed consent must be obtained from the subject together with a close caregiver, in accordance with the requirements of the ethical committee.

Exclusion Criteria:

A diagnosis of Schizophrenia, Schizo-affective disorder or paranoid disorder according to DSM IV without any suspicion cognitive decline.
Patients with the following co-existing medical conditions:
History of seizures.
Brain tumor including meningeoma.
Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances.
Clinically significant back pain.
Bleeding disorders.
Patients who, in the opinion of the investigator, are otherwise unsuitable for a trial of this type.

Sites / Locations

Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Nerve Growth Factor

Nerve Growth Factor 2

Arm Description

Dose 1

Dose 2

Outcomes

Primary Outcome Measures

Adverse events

Secondary Outcome Measures

Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)

Cognition using ADAS-Cog, neuropsychologic test battery

Full Information

NCT ID

NCT01163825

First Posted

July 14, 2010

Last Updated

July 15, 2010

Sponsor

NsGene A/S

Collaborators

Karolinska Institutet, Region Stockholm

1. Study Identification

Unique Protocol Identification Number

NCT01163825

Brief Title

Encapsulated Cell Biodelivery of Nerve Growth Factor to Alzheimer´s Disease Patients

Acronym

NsG0202

Official Title

An Open Label, Dose-Escalation Study of Encapsulated Cell Biodelivery of Nerve Growth Factor to the Cholinergic Basal Forebrain of Alzheimer´s Disease Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2008 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

NsGene A/S

Collaborators

Karolinska Institutet, Region Stockholm

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Cholinergic neurons in the basal forebrain project widely to the cerebral cortex and hippocampus. These neurons depend on nerve growth factor (NGF) from their target areas for survival. Impaired NGF supply is part of the Alzheimer's disease (AD) pathology, and the degeneration of these neurons correlates with the cognitive decline in these patients. The objective of encapsulated cell biodelivery (ECB) is to maintain normal levels of NGF to support cholinergic function. NsGene's NGF secreting ECB device (NsG0202) combines the potential benefits of targeted gene therapy with the safety of a retrievable implantable device. The study is an open label, single centre, 12-month, dose-escalation phase Ib study in patients with mild to moderate AD. The primary objective is safety and tolerability, while secondary outcomes measure include cognition, behaviour, neuropsychology, activities of daily living (ADL), positron emission tomography (PET) imaging and electroencephalography (EEG).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nerve Growth Factor

Arm Type

Experimental

Arm Description

Dose 1

Arm Title

Nerve Growth Factor 2

Arm Type

Experimental

Arm Description

Dose 2

Intervention Type

Drug

Intervention Name(s)

Nerve Growth Factor

Intervention Description

Encapsulated cell biodelivery of Nerve Growth Factor (NGF) to the basal forebrain nuclei of the brain by multiple implantable devices housing NGF-secreting human cells

Primary Outcome Measure Information:

Title

Adverse events

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)

Description

Cognition using ADAS-Cog, neuropsychologic test battery

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 50-80 years All patients must fulfil the NINDNDS-ARDRA criteria of Alzheimer's disease. The subject must have a score between 15-24 inclusive, on the mini-mental state examination (MMSE). The subject must have a caregiver who is able and committed to assist the subject to comply with the trial protocol, and who is willing to provide the information required at assessment interviews. Informed consent must be obtained from the subject together with a close caregiver, in accordance with the requirements of the ethical committee. Exclusion Criteria: A diagnosis of Schizophrenia, Schizo-affective disorder or paranoid disorder according to DSM IV without any suspicion cognitive decline. Patients with the following co-existing medical conditions: History of seizures. Brain tumor including meningeoma. Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances. Clinically significant back pain. Bleeding disorders. Patients who, in the opinion of the investigator, are otherwise unsuitable for a trial of this type.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria E Jönhagen, MD PhD

Organizational Affiliation

Karolinska University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karolinska University Hospital

City

Stockholm

ZIP/Postal Code

17176

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

32375872

Citation

Machado A, Ferreira D, Grothe MJ, Eyjolfsdottir H, Almqvist PM, Cavallin L, Lind G, Linderoth B, Seiger A, Teipel S, Wahlberg LU, Wahlund LO, Westman E, Eriksdotter M; Alzheimer's Disease Neuroimaging Initiative. The cholinergic system in subtypes of Alzheimer's disease: an in vivo longitudinal MRI study. Alzheimers Res Ther. 2020 May 6;12(1):51. doi: 10.1186/s13195-020-00620-7.

Results Reference

derived

PubMed Identifier

27389402

Citation

Eyjolfsdottir H, Eriksdotter M, Linderoth B, Lind G, Juliusson B, Kusk P, Almkvist O, Andreasen N, Blennow K, Ferreira D, Westman E, Nennesmo I, Karami A, Darreh-Shori T, Kadir A, Nordberg A, Sundstrom E, Wahlund LO, Wall A, Wiberg M, Winblad B, Seiger A, Wahlberg L, Almqvist P. Targeted delivery of nerve growth factor to the cholinergic basal forebrain of Alzheimer's disease patients: application of a second-generation encapsulated cell biodelivery device. Alzheimers Res Ther. 2016 Jul 7;8(1):30. doi: 10.1186/s13195-016-0195-9.

Results Reference

derived

PubMed Identifier

22655593

Citation

Wahlberg LU, Lind G, Almqvist PM, Kusk P, Tornoe J, Juliusson B, Soderman M, Sellden E, Seiger A, Eriksdotter-Jonhagen M, Linderoth B. Targeted delivery of nerve growth factor via encapsulated cell biodelivery in Alzheimer disease: a technology platform for restorative neurosurgery. J Neurosurg. 2012 Aug;117(2):340-7. doi: 10.3171/2012.2.JNS11714. Epub 2012 Jun 1.

Results Reference

derived

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Encapsulated Cell Biodelivery of Nerve Growth Factor to Alzheimer´s Disease Patients

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