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Alzheimer's DiseasePhase 2ALZ201NCT00785759

Brain Uptake and Safety With Probable Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers

A Phase 2 study testing AH110690 (18F) Injection in people with Alzheimer's Disease and Amnestic Mild Cognitive Impairment, run by GE Healthcare at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study to Assess Brain Uptake and Safety of AH110690 (18F) Injection in Subjects with Probable Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers. Read more about this study

Who is it for?
Ages 25 years and olderHealthy volunteers can take part
What is being tested?
AH110690 (18F) Injection
Type of treatment
Injection or infusion
How many people
78 participants
Where
1 siteNorway
Study dates
Sep 2008to Dec 2009
Phase
Phase 2
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 25 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The subject meets National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for clinically probable AD and Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for dementia of Alzheimer's type.
  • The subject meets Petersen criteria for amnestic MCI.
  • The subject has no evidence of cognitive impairment by medical history.

Who cannot join

  • The subject may not be able to complete the study as judged by the investigator.
  • The subject has received ionising radiation exposure from clinical trials in the last 12 months or has participated in any other clinical study within 30 days of study entry.
  • The subject has known allergies to [18F]AH110690 or [11C]PIB or their constituents.
  • The subject is pregnant or breast-feeding.
  • The subject has a history of alcohol and/or drug abuse within the last 2 years based upon a review of medical records.
  • The subject has a contraindication for MRI (including, but not limited to, claustrophobia, pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant).
  • The subject has a history of head injury with loss of consciousness.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • GE Healthcare

    Oslo

Other trials in Norway

About this study

Official title: An Open-label Study to Assess Brain Uptake and Safety of AH110690 (18F) Injection in Subjects With Probable Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers

Study to Assess Brain Uptake and Safety of AH110690 (18F) Injection in Subjects with Probable Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers.

Being tested
AH110690 (18F) Injection
Keywords
Alzheimer's Disease
Medical subject headings
Alzheimer Disease

What participants receive

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

  • AH110690 (18F) InjectionDrug

    All subjects will receive an I.V. dose of [18F]AH110690 (less than 10 mg of total AH110690). The target activity of a single administration of [18F]AH110690 will be 185 MBq (equivalent to a dose of approximately 6 mSv).

What is being measured

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

  1. Examine the efficacy and determine visual assessment of raised [18F] brain uptake for separating subjects with probable Alzheimer's Disease from healthy volunteers and assigning amnestic mild cognitive impairment cases to an AD or HV category.

    Measured: September 2008 - February 2009

Secondary outcomes (1)

  1. Examine the efficacy and parameters of brain [18F] uptake for separating 25 subjects with probable AD from 25 HV, assigning 20 amnestic MCI cases to an AD or HV category by measuring ranges of regional cerebral to cerebellum tracer uptake ratios.

    Measured: September 2008 - February 2009

Timeline

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

  1. First posted5 Nov 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionMar 2009
  4. Study completionDec 2009

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 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00785759
Sponsor's protocol ID
ALZ201
Acronym
ALZ201
Status last verified
Dec 2009
First submitted
4 Nov 2008
Last updated
7 Dec 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AH110690 (18F) Injection in people with Alzheimer's Disease and Amnestic Mild Cognitive Impairment, run by GE Healthcare at 1 site in Norway.

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 3 inclusion and 7 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: finished, as of the sponsor's last update on 7 Dec 2009. 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 Norway. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Examine the efficacy and determine visual assessment of raised [18F] brain uptake for separating subjects with probable Alzheimer's Disease from healthy volunteers and assigning amnestic mild cognitive impairment cases to an AD or HV category. (time frame: September 2008 - February 2009). 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 NCT00785759.

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 7 Dec 2009.

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