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NsG0202

UnknownPhase 1

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

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

Lead sponsor

NsGene A/S

Asset

Nerve Growth Factor

Listed sites

1

Recruiting sites

-

Enrollment

6

actual

Study population

Alzheimer’s disease

Key I/E criteria

MMSE 15-24Study partner/caregiver required

Primary endpoint

Adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01163825
Org study IDNsG0202-001

Timeline

Milestones

Study start2008-01 (month precision)
Study first posted2010-07-16estimated
Last update posted2010-07-16estimated
Primary completion2011-12estimated (month precision)

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Age 50-80 years

2. All patients must fulfil the NINDNDS-ARDRA criteria of Alzheimer's disease.

3. The subject must have a score between 15-24 inclusive, on the mini-mental state examination (MMSE).

4. 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.

5. Informed consent must be obtained from the subject together with a close caregiver, in accordance with the requirements of the ethical committee

Exclusion criteria

1. A diagnosis of Schizophrenia, Schizo-affective disorder or paranoid disorder according to DSM IV without any suspicion cognitive decline.

2. Patients with the following co-existing medical conditions:

3. History of seizures.

4. Brain tumor including meningeoma.

5. Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances.

6. Clinically significant back pain.

7. Bleeding disorders.

8. Patients who, in the opinion of the investigator, are otherwise unsuitable for a trial of this type.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
1
Safety / tolerability / PK
1

Global cognition

1 endpoint
Secondary/protocol endpoint

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

Time frame:12 months

ADAS-Cog

descriptive

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Adverse events

Time frame:12 months

event count, event

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.