Mild Cognitive Impairment, So StatedPhase 2NCT00422981
Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment
A Phase 2 study testing AL-108 in people with Mild Cognitive Impairment, So Stated, run by Allon Therapeutics at 17 sites in United States.
Trial summary
The purpose of this study is to find out if different doses of Investigational Drug are safe, tolerable, and if they have an effect on Mild Cognitive Impairment (MCI). Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, So Stated
- What is being tested?
- AL-108
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 17 sitesUnited States
- Study dates
- Jan 2007to Jan 2008
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is male or female, at 55-85 years of age (inclusive) at screening
- Self-reported memory complaint, corroborated by spouse or companion as appropriate.
- Wechsler Memory Scale III (WMS-III) age-adjusted Logical Memory II score ≤ 5.
- Mini-Mental State Exam (MMSE) ≥24.
- Center for Epidemiologic Studies-Depression (CES-D) score <27.
- Normal thyroid function, defined as TSH, T3 and T4 within normal limits.
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- Agree not to consume alcoholic beverages within 8 hours of each study visit.
- Willing and able to sign informed consent and complete the CTB and all other tests and procedures as listed in the protocol.
- Fluently reads and speaks English.
- Female subjects must be surgically sterile or post-menopausal for at least 2 years. If <2 years post-menopausal, then a follicle stimulating hormone (FSH) ≥40 mIU/mL must be obtained.
Who cannot join
- Subjects who have any significant, untreated psychiatric illness or any CNS condition (such as schizophrenia, Parkinson's disease, stroke, etc.) that could interfere with the study evaluations or procedures or which poses an additional risk. Subjects with a history of uncomplicated depression may participate if in remission and on a stable dose of antidepressant medication for at least 2 months.
- History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
- History of alcohol or substance abuse or dependence within the past year.
- Acute infective sinusitis.
- History or presence of an abnormality of the external or internal structures of the nose or nasopharynx, except for surgical correction of the nasal septum or a "broken nose" at least 2 years previously, or surgical repair of cleft palate when <30 years of age.
- Use of medications that are known to cause frank obtundation of cognition
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- Use of any approved or investigational medication for Alzheimer's Disease within 3 months of screening
- History of or current significant systemic disease judged to interfere with the study evaluations or likely to be a safety concern.
- Untreated sleep apnea or treatment for sleep apnea for <3 months.
- Abnormal clinical laboratory test results, specifically: Alanine transaminase (ALT) or aspartate transaminase (AST) >2 х the upper limit of normal (ULN),Hematology <80% the lower limit of normal, Creatinine ≥2 mg/dL and ,Other clinical laboratory values or vital signs considered clinically significant in the opinion of the Investigator.
- Treatment with any investigational drug, biologic, or device within the previous 30 days prior to screening.
- Surgery involving general anesthesia within the past 3 months or planned surgery requiring general anesthesia during the study period.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Senior Adults Speciality Research
Austin, Texas, 78757
SPRI Clinical trials
Brooklyn, New York, 11235
Meridien Research
Brooksville, Florida, 34613
Collaborative Neuroscience Network
Garden Grove, California, 92845
Comprehensive Neuroscience
Hoffman Estates, Illinois, 60194
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216
The Memory Enhancement Center of America
Long Branch, New Jersey, 07740
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, 38119
Synergy Research
National City, California, 91950
Clinical Neuroscience Solutions
Orlando, Florida, 32806
Pivotal Research
Peoria, Arizona, 85381
Pacific Research Network, Inc
San Diego, California, 92103
Meridien Research
Tampa, Florida, 33606
Stedman Clinical Trials
Tampa, Florida, 33613
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, 43623
Clinical Research Center of Indian River Medical Center
Vero Beach, Florida, 32960
Memory Assessment and Research Services
Wilmington, North Carolina, 28405
About this study
Official title: A Phase 2, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Effect on Cognitive Function of AL-108 After 12 Weeks of Intranasal Administration in Subjects With Mild Cognitive Impairment
The purpose of this study is to find out if different doses of Investigational Drug are safe, tolerable, and if they have an effect on Mild Cognitive Impairment (MCI).
Read the detailed description
Pre-Clinical experiments indicate the AL-108 compound has neuroprotective, cognitive protective and neurotrophic properties; therefore, the compound could be tested in a variety of human diseases. Human diseases include Cognitive impairment associated with aging or neurodegenerative diseases such as Alzheimer's Disease.
This clinical trial aims at providing the dose rationale as well as safety and tolerability information for AL-108 as evaluated after 12 weeks of intranasal administration in subjects with Mild Cognitive Impairment (MCI).
There are currently no drugs approved for the treatment of MCI nor accepted treatment or standard treatment approach.
- Conditions
- Mild Cognitive Impairment, So Stated
- Being tested
- AL-108, Placebo
- Keywords
- Dementia, Memory, Alzheimers, Cognition, Mind, Aging
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-108Drug
5 mg QD
AL-108Drug
15 mg BID
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AL-108 5 mg | Active comparator | 5 mg QD Receives: Drug: AL-108 |
| AL-108 15 mg | Active comparator | 15 mg BID Receives: Drug: AL-108 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Week 12 on the Composite Memory Variable
Measured: 12 weeks
Secondary outcomes (2)
Changes in the Composite Memory Variable from baseline to weeks 4, 8, and 16
Measured: 16 weeks
Changes in test battery individual items from baseline to endpoints (weeks 4, 8, 12, and 16).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment, So StatedStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald E Schmechel, MD, Principal investigator, Memory Assessment and Research Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422981
- Sponsor's protocol ID
- AL-108-211
- Status last verified
- Oct 2012
- First submitted
- 16 Jan 2007
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Gozes I, Blatt J, Lobyntseva A. Davunetide sex-dependently boosts memory in prodromal Alzheimer's disease. Transl Psychiatry. 2024 Oct 2;14(1):412. doi: 10.1038/s41398-024-03118-0.
PubMed 39358355Morimoto BH, Schmechel D, Hirman J, Blackwell A, Keith J, Gold M; AL-108-211 Study. A double-blind, placebo-controlled, ascending-dose, randomized study to evaluate the safety, tolerability and effects on cognition of AL-108 after 12 weeks of intranasal administration in subjects with mild cognitive impairment. Dement Geriatr Cogn Disord. 2013;35(5-6):325-36. doi: 10.1159/000348347. Epub 2013 Apr 13.
PubMed 23594991
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Effect on Cognitive Function of AL-108 After 12 Weeks of Intranasal Administration in Subjects With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT00422981
- Acronym / sponsor ID
- AL-108-211
- Conditions
- Mild Cognitive Impairment, So Stated
- Keywords
- Dementia, Memory, Alzheimers, Cognition, Mind, Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Allon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 17 Jan 2007 (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.
The purpose of this study is to find out if different doses of Investigational Drug are safe, tolerable, and if they have an effect on Mild Cognitive Impairment (MCI).
Detailed description
Pre-Clinical experiments indicate the AL-108 compound has neuroprotective, cognitive protective and neurotrophic properties; therefore, the compound could be tested in a variety of human diseases. Human diseases include Cognitive impairment associated with aging or neurodegenerative diseases such as Alzheimer's Disease.
This clinical trial aims at providing the dose rationale as well as safety and tolerability information for AL-108 as evaluated after 12 weeks of intranasal administration in subjects with Mild Cognitive Impairment (MCI).
There are currently no drugs approved for the treatment of MCI nor accepted treatment or standard treatment approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AL-108 5 mg | Active comparator | Drug: AL-1085 mg QD |
| AL-108 15 mg | Active comparator | Drug: AL-10815 mg BID |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Is male or female, at 55-85 years of age (inclusive) at screening
- Self-reported memory complaint, corroborated by spouse or companion as appropriate.
- Wechsler Memory Scale III (WMS-III) age-adjusted Logical Memory II score ≤ 5.
- Mini-Mental State Exam (MMSE) ≥24.
- Center for Epidemiologic Studies-Depression (CES-D) score <27.
Key exclusion criteria (12 listed)
- Subjects who have any significant, untreated psychiatric illness or any CNS condition (such as schizophrenia, Parkinson's disease, stroke, etc.) that could interfere with the study evaluations or procedures or which poses an additional risk. Subjects with a history of uncomplicated depression may participate if in remission and on a stable dose of antidepressant medication for at least 2 months.
- History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
- History of alcohol or substance abuse or dependence within the past year.
- Acute infective sinusitis.
- History or presence of an abnormality of the external or internal structures of the nose or nasopharynx, except for surgical correction of the nasal septum or a "broken nose" at least 2 years previously, or surgical repair of cleft palate when <30 years of age.
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 |
|---|---|---|
| AL-1085 mg QD | Drug | AL-108 5 mg |
| AL-10815 mg BID | Drug | AL-108 15 mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change from baseline to Week 12 on the Composite Memory Variable
Time frame: 12 weeks
2 secondary outcomes
Changes in the Composite Memory Variable from baseline to weeks 4, 8, and 16
Time frame: 16 weeks
Changes in test battery individual items from baseline to endpoints (weeks 4, 8, 12, and 16).
Time frame: 16 weeks
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 24 Oct 2012.
- Derived from this study: PubMed 39358355Gozes I, Blatt J, Lobyntseva A. Davunetide sex-dependently boosts memory in prodromal Alzheimer's disease. Transl Psychiatry. 2024 Oct 2;14(1):412. doi: 10.1038/s41398-024-03118-0.
- Derived from this study: PubMed 23594991Morimoto BH, Schmechel D, Hirman J, Blackwell A, Keith J, Gold M; AL-108-211 Study. A double-blind, placebo-controlled, ascending-dose, randomized study to evaluate the safety, tolerability and effects on cognition of AL-108 after 12 weeks of intranasal administration in subjects with mild cognitive impairment. Dement Geriatr Cogn Disord. 2013;35(5-6):325-36. doi: 10.1159/000348347. Epub 2013 Apr 13.
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.
Donald E Schmechel, MD principal investigator
Memory Assessment and Research Services
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AL-108 in people with Mild Cognitive Impairment, So Stated, run by Allon Therapeutics at 17 sites in United States.
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 10 inclusion and 12 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 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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. Some participants in this study may receive a placebo. 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?
Change from baseline to Week 12 on the Composite Memory Variable (time frame: 12 weeks). 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 NCT00422981, which also lists 2 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 24 Oct 2012.