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Alzheimer's DiseasePhase 1NsG0202NCT01163825

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

A Phase 1 study testing Nerve Growth Factor in people with Alzheimer's Disease, run by NsGene A/S at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Nerve Growth Factor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteSweden
Study dates
Jan 2008to Dec 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska University Hospital

    Stockholm, 17176

Other trials in Sweden

About this study

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

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).

Being tested
Nerve Growth Factor
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nerve Growth FactorDrug

    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

Study groups in NCT01163825
Study groupRoleWhat they receive
Nerve Growth FactorExperimentalDose 1
Receives: Drug: Nerve Growth Factor
Nerve Growth Factor 2ExperimentalDose 2
Receives: Drug: Nerve Growth Factor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Measured: 12 months

Secondary outcomes (1)

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

    Cognition using ADAS-Cog, neuropsychologic test battery

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2010 (estimated)
  2. Study startJan 2008
  3. Primary completionDec 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01163825
Sponsor's protocol ID
NsG0202-001
Acronym
NsG0202
Status last verified
Jul 2010
First submitted
14 Jul 2010
Last updated
16 Jul 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32375872

  • 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.

    PubMed 27389402

  • 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.

    PubMed 22655593

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nerve Growth Factor in people with Alzheimer's Disease, run by NsGene A/S at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01163825, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2010.

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