Memory DisordersPhase 1NCT00000180
AIT-082 Phase 1B Study
A Phase 1 study testing AIT-082 in people with Memory Disorders, run by National Institute on Aging (NIA) at 4 sites in United States.
Trial summary
AIT-082 is a novel small molecule that crosses the blood-brain barrier to enhance nerve function by increasing levels of neurotrophic growth factors and encouraging nerve sprouting in the brain. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Memory Disorders
- What is being tested?
- AIT-082
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Start not givento Jun 2005
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109-0322
Indiana University Alzheimer's Center
Indianapolis, Indiana, 46202
University of California, San Diego
San Diego, California, 92093-0949
Washington University
St Louis, Missouri, 63110
About this study
AIT-082 is a novel small molecule that crosses the blood-brain barrier to enhance nerve function by increasing levels of neurotrophic growth factors and encouraging nerve sprouting in the brain. Preclinical studies in animals have shown that AIT-082 improves memory in aged animals and in animals with neurological deficits.
This study was a double-blind placebo-controlled safety study that was designed to study whether AIT-082 may delay age-related mental decline. Eight healthy older volunteers at two clinical sites were given single, weekly, rising doses of AIT-082 or placebo for 5 weeks; were tested for side effects and absorption; and underwent a battery of neuropsychological memory tests, including word and number recall tests.
- Conditions
- Memory Disorders
- Being tested
- AIT-082
- Keywords
- Memory, Mild cognitive impairment, Nerve growth factors
- Medical subject headings
- Memory Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIT-082Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 1999 (estimated)
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Memory DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Michael Grundman, M.D., M.P.H., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000180
- Sponsor's protocol ID
- IA0008
- Other IDs
- 3U01AG010483-08S2
- Status last verified
- Feb 2005
- First submitted
- 29 Oct 1999
- Last updated
- 11 Dec 2009
- Results posted
- No
Publications
Grundman M, Capparelli E, Kim HT, Morris JC, Farlow M, Rubin EH, Heidebrink J, Hake A, Ho G, Schultz AN, Schafer K, Houston W, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, randomized, placebo controlled, multiple-dose, safety and pharmacokinetic study of AIT-082 (Neotrofin) in mild Alzheimer's disease patients. Life Sci. 2003 Jun 20;73(5):539-53. doi: 10.1016/s0024-3205(03)00320-5.
PubMed 12770610
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIT-082 Phase 1B Study
- ClinicalTrials.gov ID
- NCT00000180
- Acronym / sponsor ID
- IA0008
- Conditions
- Memory Disorders
- Keywords
- Memory, Mild cognitive impairment, Nerve growth factors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 1 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AIT-082 is a novel small molecule that crosses the blood-brain barrier to enhance nerve function by increasing levels of neurotrophic growth factors and encouraging nerve sprouting in the brain. Preclinical studies in animals have shown that AIT-082 improves memory in aged animals and in animals with neurological deficits.
This study was a double-blind placebo-controlled safety study that was designed to study whether AIT-082 may delay age-related mental decline. Eight healthy older volunteers at two clinical sites were given single, weekly, rising doses of AIT-082 or placebo for 5 weeks; were tested for side effects and absorption; and underwent a battery of neuropsychological memory tests, including word and number recall tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIT-082 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
- Results publication: PubMed 12770610Grundman M, Capparelli E, Kim HT, Morris JC, Farlow M, Rubin EH, Heidebrink J, Hake A, Ho G, Schultz AN, Schafer K, Houston W, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, randomized, placebo controlled, multiple-dose, safety and pharmacokinetic study of AIT-082 (Neotrofin) in mild Alzheimer's disease patients. Life Sci. 2003 Jun 20;73(5):539-53. doi: 10.1016/s0024-3205(03)00320-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Grundman, M.D., M.P.H. principal investigator
University of California, San Diego
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AIT-082 in people with Memory Disorders, run by National Institute on Aging (NIA) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 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 4 sites in United States. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000180, which also lists 1 linked publication.
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 11 Dec 2009.