Alzheimer DiseasePhase 3NCT00000174
Investigation Into Delay to Diagnosis of Alzheimer's Disease With Exelon (InDDEx)
A Phase 3 study testing Rivastigmine in people with Alzheimer Disease and Cognition Disorders, run by Novartis at 15 sites in United States.
Trial summary
This phase IIIb trial is a prospective, randomized, double-blind, placebo-controlled, 36-month study comparing the length of time of progression from mild cognitive impairment (MCI) to a clinical diagnosis of Alzheimer's disease (AD) in subjects taking Exelon vs. placebo. Exelon is currently under review with the U.S. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer Disease, Cognition Disorders
- What is being tested?
- Rivastigmine
- How many people
- Not given
- Where
- 15 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are aged 55-85 years, inclusive. Subjects older than 85 years may be eligible to participate, with approval of the designated study medical monitor.
- Are male or female without child-bearing potential (i.e., surgically sterilized [via bilateral tubal ligation,bilateral oophorectomy, or hysterectomy], at least one year postmenopausal, or using adequate birth control).
- Are cooperative, able to ingest oral medication, and willing to complete all aspects of the study.
- Will provide written informed consent prior to their participation in the study.
- Show evidence of mild cognitive impairment (MCI) by meeting all of the following criteria: Global CDR score = 0.5, NYU Delayed Paragraph Recall less than 9, 17-item HAM-D score less than 13, and HAM-D Item 1 (depressed mood) score =1.
- Have a friend or family member who is willing to participate in the study as an informant. The informant must see the subject at least once a week for several hours and be available to accompany the subject to the screening and baseline visits, and at a minimum, be accessible by telephone for other scheduled visits.
Who cannot join
- Advanced, severe, and unstable disease of any type that may interfere with primary and secondary variable evaluations including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the subject to a significant degree or put the subject at special risk.
- Cognitive impairment sufficient to warrant a diagnosis of dementia.
- Met the DSM-IV and NINCDS-ADRDA criteria for AD.
- A clinical diagnosis of AD.
- A DSM-IV Axis 1 diagnosis. However, subjects with current depression are eligible after appropriate treatment of the depressive episode. A minimum of four weeks washout of antidepressant medication should occur prior to screening. Subjects with a prior history of depression (but not currently depressed) are allowed in the study.
- Fewer than four years of formal education.
Show all 25Show fewer
- A documented history of transient ischemic attacks.
- Baseline MRI findings or CT-scan findings within a year of screening that are consistent with a process other than AD, e.g., stroke, tumor, brain trauma or hydrocephalus, that may contribute to the subject's MCI. Lacunae infarcts present in areas affecting cognition (entorhinal cortex, hippocampus, medial temporal lobe) will also exclude the subject from the study.
- A score of greater than 4 on the Modified Hachinski Ischemic Scale.
- A current diagnosis of any primary neurodegenerative disorder, e.g., Parkinson's disease.
- A current diagnosis of uncontrolled seizure disorder.
- A current diagnosis of active peptic ulceration.
- A current diagnosis of severe and unstable cardiovascular disease.
- A current diagnosis of sick-sinus syndrome or conduction deficits (sino-atrial block, second or third degree atrio-ventricular block).
- A current diagnosis of acute, severe, or unstable asthmatic conditions.
- A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to Exelon or to other cholinergic compounds (e.g., pilocarpine, bethanechol, tacrine, velnacrine, donepezil, metrifonate, or physostigmine). Subjects who have experienced elevations in liver function test parameters on other cholinesterase inhibitors are still eligible.
- Taken any of the following substances: An investigational drug during the past four weeks; Metrifonate during the past three months; a drug or treatment known to cause major organ system toxicity during the past four weeks; other cholinergic drugs (e.g., donepezil, tacrine, succinylcholine-type muscle relaxants) during the past two weeks (topical pilocarpine will be permitted); antidepressant medication during the past four weeks.
- Participated in a previous clinical trial of Exelon.
- Clinically important laboratory abnormalities in serum B12, folate, or T3/T4 at screening. The subject should be excluded if peripheral neuropathy, macrocytic anemia, or myxedema is present.
- If screen values do not meet the absolutely exclusionary values given below but are still outside the normal reference range, treatment for folic acid/B12 deficiency or thyroid disorder, as appropriate, may be initiated or adjusted with re-evaluation of the subject within three months. Within these three months of treatment, the subject's cognitive condition must be clinically unchanged or worse for the subject to be acceptable. Once accepted, the subject must remain on the appropriate treatment throughout the study.
- Exclude if T3 uptake is less than 19%; T4 less than 2.9 ((g/dL); free T4 index is less than 0.8
- Exclude if folate less than 1.7 ng/ml (normal range greater than 1.9)
- Exclude if B12 less than 100 pg/ml (normal range greater than 200)
- A positive rapid plasmin reagin test followed up by a positive serological test for syphilis.
- A disability that may prevent the subject from completing all study requirements (e.g., blindness, deafness, severe language difficulty).
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
St. Paul Medical Center
Dallas, Texas, 75235
University of Colorado Health Sciences Center
Denver, Colorado, 80220
Duke University Medical Center
Durham, North Carolina, 27710
Neuromedical Research Institute (Offices in Ft. Lauderdale, Miami Beach and Boca Raton)
Fort Lauderdale, Florida, 33321
Indiana University Alzheimer's Center
Indianapolis, Indiana, 46202
Alzheimer's Research Corporation
Lakewood, New Jersey, 08701
Miami Research Associates
Miami, Florida, 33176
NYU Medical Center
New York, New York, 10016
Pahl Brain Associates, P.C.
Oklahoma City, Oklahoma, 73118
University of California, Irvine
Orange, California, 92868
Medici Research Centers
Peoria, Arizona, 85381
Clinical Studies, Ltd., Philadelphia
Philadelphia, Pennsylvania, 19106
University of Washington, Seattle
Seattle, Washington, 98108
St. Louis University
St Louis, Missouri, 63104
Center for Clinical Trials and Research
Venice, Florida, 34285
About this study
This phase IIIb trial is a prospective, randomized, double-blind, placebo-controlled, 36-month study comparing the length of time of progression from mild cognitive impairment (MCI) to a clinical diagnosis of Alzheimer's disease (AD) in subjects taking Exelon vs. placebo. Exelon is currently under review with the U.S. Food and Drug Administration as a treatment for Alzheimer's disease. The drug has been cleared for marketing in more than 40 countries for Alzheimer's disease to date, including all 15 member states of the European Union, New Zealand, Argentina, Brazil and Mexico.
Each subject with MCI will be randomly assigned to treatment with either Exelon or placebo. Subjects assigned to Exelon will receive 1.5 to 6.0 mg bid (twice daily) (3.0 to 12 mg/day) for the majority of the study. At every regular visit scheduled every three months, patients will be given basic efficacy and safety assessments. These assessments will include evaluation of adverse events, vital signs, activities of daily living, and clinical staging scales to determine if the subject may have converted to dementia.
- Conditions
- Alzheimer Disease, Cognition Disorders
- Being tested
- Rivastigmine
- Keywords
- Mild cognitive impairment, Alzheimer's disease, Memory, Cholinergic agents, Cholinesterase inhibitors
- Medical subject headings
- Alzheimer Disease, Cognition Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivastigmineDrug
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)
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 Alzheimer DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Ferris, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000174
- Sponsor's protocol ID
- IA0012
- Status last verified
- Jan 2000
- First submitted
- 29 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Feldman HH, Ferris S, Winblad B, Sfikas N, Mancione L, He Y, Tekin S, Burns A, Cummings J, del Ser T, Inzitari D, Orgogozo JM, Sauer H, Scheltens P, Scarpini E, Herrmann N, Farlow M, Potkin S, Charles HC, Fox NC, Lane R. Effect of rivastigmine on delay to diagnosis of Alzheimer's disease from mild cognitive impairment: the InDDEx study. Lancet Neurol. 2007 Jun;6(6):501-12. doi: 10.1016/S1474-4422(07)70109-6.
PubMed 17509485
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into Delay to Diagnosis of Alzheimer's Disease With Exelon (InDDEx)
- ClinicalTrials.gov ID
- NCT00000174
- Acronym / sponsor ID
- IA0012
- Conditions
- Alzheimer Disease, Cognition Disorders
- Keywords
- Mild cognitive impairment, Alzheimer's disease, Memory, Cholinergic agents, Cholinesterase inhibitors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- 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.
This phase IIIb trial is a prospective, randomized, double-blind, placebo-controlled, 36-month study comparing the length of time of progression from mild cognitive impairment (MCI) to a clinical diagnosis of Alzheimer's disease (AD) in subjects taking Exelon vs. placebo. Exelon is currently under review with the U.S. Food and Drug Administration as a treatment for Alzheimer's disease. The drug has been cleared for marketing in more than 40 countries for Alzheimer's disease to date, including all 15 member states of the European Union, New Zealand, Argentina, Brazil and Mexico.
Each subject with MCI will be randomly assigned to treatment with either Exelon or placebo. Subjects assigned to Exelon will receive 1.5 to 6.0 mg bid (twice daily) (3.0 to 12 mg/day) for the majority of the study. At every regular visit scheduled every three months, patients will be given basic efficacy and safety assessments. These assessments will include evaluation of adverse events, vital signs, activities of daily living, and clinical staging scales to determine if the subject may have converted to dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are aged 55-85 years, inclusive. Subjects older than 85 years may be eligible to participate, with approval of the designated study medical monitor.
- Are male or female without child-bearing potential (i.e., surgically sterilized [via bilateral tubal ligation,bilateral oophorectomy, or hysterectomy], at least one year postmenopausal, or using adequate birth control).
- Are cooperative, able to ingest oral medication, and willing to complete all aspects of the study.
- Will provide written informed consent prior to their participation in the study.
- Show evidence of mild cognitive impairment (MCI) by meeting all of the following criteria: Global CDR score = 0.5, NYU Delayed Paragraph Recall less than 9, 17-item HAM-D score less than 13, and HAM-D Item 1 (depressed mood) score =1.
Key exclusion criteria (25 listed)
- Advanced, severe, and unstable disease of any type that may interfere with primary and secondary variable evaluations including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the subject to a significant degree or put the subject at special risk.
- Cognitive impairment sufficient to warrant a diagnosis of dementia.
- Met the DSM-IV and NINCDS-ADRDA criteria for AD.
- A clinical diagnosis of AD.
- A DSM-IV Axis 1 diagnosis. However, subjects with current depression are eligible after appropriate treatment of the depressive episode. A minimum of four weeks washout of antidepressant medication should occur prior to screening. Subjects with a prior history of depression (but not currently depressed) are allowed in the study.
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 |
|---|---|---|
| Rivastigmine | 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 24 Jun 2005.
- Derived from this study: PubMed 17509485Feldman HH, Ferris S, Winblad B, Sfikas N, Mancione L, He Y, Tekin S, Burns A, Cummings J, del Ser T, Inzitari D, Orgogozo JM, Sauer H, Scheltens P, Scarpini E, Herrmann N, Farlow M, Potkin S, Charles HC, Fox NC, Lane R. Effect of rivastigmine on delay to diagnosis of Alzheimer's disease from mild cognitive impairment: the InDDEx study. Lancet Neurol. 2007 Jun;6(6):501-12. doi: 10.1016/S1474-4422(07)70109-6.
- The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA).Link provided by the sponsor.
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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.
Steven Ferris, PhD principal investigator
NYU Langone Health
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivastigmine in people with Alzheimer Disease and Cognition Disorders, run by Novartis at 15 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 6 inclusion and 25 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 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 NCT00000174, 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 24 Jun 2005.