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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00785759

Acronym

ALZ201

Enrollment

Registered

2008-11-05

Start date

2008-09-30

Completion date

2009-12-31

Last updated

2009-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Amnestic Mild Cognitive Impairment

Keywords

Alzheimer's Disease

Brief 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.

Interventions

DRUGAH110690 (18F) Injection

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
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.	September 2008 - February 2009

Secondary

Measure	Time frame
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.	September 2008 - February 2009

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026